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PubMed1980

Chronic immunologic thrombocytopenic purpura: results of cyclophosphamide therapy before splenectomy.

Corticosteroids, cyclophosphamide, and splenectomy were employed in the treatment of 43 patients with immunologic thrombocytopenic purpura. All received corticosteroids initially; 22 patients received corticosteroids and cyclophosphamide, and six received drug treatment and underwent splenectomy. Of those receiving corticosteroids alone, 11 had excellent responses and ten had good responses. Of those receiving corticosteroids and cyclophosphamide, responses to treatment were excellent in six, good in eight, and fair in two. Of those receiving drug treatment and undergoing splenectomy, the responses to treatment were excellent in four, good in one, and fair in one. The duration required for induction of remission indicated the prognosis for patients; excellent responses were observed at 1, 2.4, and 4 months in groups treated, respectively, with corticosteroids, corticosteroids and cyclophosphamide, and drugs plus splenectomy.

Adolescent↗

PubMed1994

The effect of cyclophosphamide on development of experimental cholesteatoma.

BACKGROUND: Recent work has shown that middle ear application of propylene glycol in chinchillas produces an inflammatory reaction resulting in cholesteatoma formation in 50% to 70% of animals. This study was done to determine if cyclophosphamide, an immune suppressor and anti-inflammatory agent, is capable of inhibiting cholesteatoma development in the animal model. METHODS: Ten adult chinchillas received systemic cyclophosphamide (20 mg/kg per day) for 14 days. On days 5, 8, and 11 of that period, the animals also received bilateral middle ear applications of 60% propylene glycol (0.2 mL per ear). Four weeks after the first propylene glycol application, the animals were killed for histologic evaluation. RESULTS: Eight of the 10 animals survived the full 4-week study period, providing 16 temporal bones for evaluation. It was found that cyclophosphamide reduced the leukocyte counts; however, middle ear inflammation appeared unaffected. Cholesteatoma occurred in eight (50%) of the 16 ears studied, and histologic findings were essentially identical to those previously seen in animals given propylene glycol alone. CONCLUSION: Under the conditions of this study, cyclophosphamide had no effect on cholesteatoma development in the animal model.

Administration, Topical↗

PubMed1975

Pseudomonas aeruginosa infection in mice after treatment with cyclophosphamide.

This study attempted to determine if the antineoplastic alkylating agent, cyclophosphamide (Cytoxan), altered the host response to Pseudomonas aeruginosa infection in mice. The effect of cyclophosphamide was evaluated by an increased mortality or enhanced bacterial growth in the liver, lungs, spleen, and kidneys. The mice that were treated with either single or multiple doses of 25 mg/kg cyclophosphamide showed no increase in mortality, nor did they exhibit an enhanced localization of P aeruginosa in any of the organs studied. Higher dose levels of cyclophosphamide produced a statistically significant increase in mortality and greater distribution of bacteria in the mouse organs, but there appeared to be no organ that was particularly susceptible to infection.

Animals↗

PubMed1998

Activity of high-dose cyclophosphamide in the treatment of childhood malignant gliomas.

Seventeen patients less than or equal to 20 years of age with newly diagnosed (n = 10) or recurrent (n = 7) malignant gliomas (anaplastic astrocytoma and glioblastoma multiforme) were treated with cyclophosphamide in association with hematopoietic cytokines (GM-CSF or G-CSF). Cyclophosphamide was given at a dose of 2 g/m2 daily for 2 days at 4-week intervals. Toxicity consisted of grade IV neutropenia and thrombocytopenia in 95% and 48% of cycles, respectively. There were no cyclophosphamide-related cardiac, pulmonary, or urothelial toxicities observed. Four of 10 patients with newly diagnosed disease demonstrated responses (three complete and one partial responses; one CR was only of 2 months duration). None of the seven patients with recurrent tumors demonstrated a response. We conclude that high-dose cyclophosphamide warrants further evaluation in children with newly diagnosed malignant glioma.

Adolescent↗

PubMed2000

Hematopoietic stem cell transplantation (HSCT) with a conditioning regimen of busulfan, cyclophosphamide, and etoposide for children with acute myelogenous leukemia (AML): a phase I study of the Pediatric Blood and Marrow Transplant Consortium.

BACKGROUND: Hematopoietic stem cell transplantation (HSCT) is an important treatment modality for children with AML. The optimal conditioning regimen is unknown. The aim of this study was to determine the appropriate dosing of etoposide in combination with busulfan and cyclophosphamide in this setting. PROCEDURE: Twenty patients with a diagnosis of AML in first or second remission, or myelodysplasia scheduled for bone marrow transplantation, were included in this study. Patients received busulfan 640 mg/m(2) in 16 doses, cyclophosphamide 120 to 150 mg/kg in two doses, and etoposide from 40-60 mg/kg as a single dose. Extensive toxicity data was collected. RESULTS: Nineteen patients were evaluable for toxicity. Mucositis was seen in all patients. Four patients developed bacteremia and one patient died from overwhelming sepsis on day +3. Four patients developed moderate to severe skin toxicity. The major dose-limiting +3 toxicity was hepatic toxicity, which occurred in 14 of 19 patients. Eight patients developed clinical veno-occlusive disease, including three patients at dose level 4, two of whom had life-threatening disease. This hepatic toxicity defined the MTD of 640 mg/m(2) busulfan, 120 mg/kg of cyclophosphamide, and 60 mg/kg of etoposide. Overall, 9 of 20 patients enrolled in the study survive in remission, 8/14 allogeneic (median follow-up 44 months), and one of six autologous patients (follow-up, 54 months). CONCLUSIONS: We conclude that the combination of busulfan, cyclophosphamide, and etoposide at the doses defined above has activity in the treatment of children with high-risk AML/MDS undergoing allogeneic HSCT. Whether it offers an advantage over other conditioning regimens will require a randomized trial with a larger cohort of patients.

Adolescent↗

PubMed1977

Combination chemotherapy with bleomycin, cyclophosphamide and dactinomycin for the treatment of osteogenic sarcoma.

Thirteen patients with osteogenic sarcoma were treated with multiple drug chemotherapy consisting of bleomycin, cyclophosphamide and dactinomycin. The dosage schedule used was: bleomycin 12 mg/m2/day, cyclophosphamide 600 mg/m2/day, and dactinomycin 450 microgram/m2/day. All drugs were given intravenously for two consecutive days. Treatment was repeated every 2 weeks. Toxicity included severe nausea and vomiting (managed with antiemetics and intravenous hydration) and manifestations of bone marrow depression. Of 13 patients, eight were previously treated with high dose methotrexate with citrovorum factor rescue, cyclophosphamide and Adriamycin. Of these eight, three patients had objective evidence of tumor regression (37.5%). Five of five previously untreated patients had objective evidence of tumor regression. The overall response rate in osteogenic sarcoma patients to BCD was 61.5%. The combination of BCD appears to be more active against osteogenic sarcoma than cyclophosphamide alone or Adriamycin alone. The relative safety with which BCD can be administered makes this combination a valuable adjunct to high dose methotrexate with citrovorum factor rescue and Adriamycin in the treatment of osteogenic sarcoma.

Adolescent↗

PubMed1979

Cyclophosphamide-induced cardiomyopathy: a report of two cases and review of the English literature.

Fatal cardiomyopathy developed in two patients receiving cyclophosphamide in preparation for bone marrow transplantation. Both patients had normal EKGs prior to receiving cyclophosphamide in total doses of 168 mg/kg (case 1) and 144 mg/kg (case 2) and subsequently developed loss of voltage and ST-T wave changes. One patient (case 1) died of CHF and hypotension while the other patient (case 2) developed tamponade. Prior to this report, the lowest total dose of cyclophosphamide reported to cause fatal cardiomyopathy was 180 mg/kg. In contrast to anthracycline congestive cardiomyopathy, the effects of cyclophosphamide appear to have an acute onset and do not appear to be the cumulative result of drug dosing. Postmortem examination in both patients revealed thickened left ventricles with intramyocardial hemorrhage.

Adolescent↗

PubMed1979

Cyclophosphamide plus 5-(3,3-dimethyl-1-triazeno)-imidazole-4-carboxamide (DTIC) with or without Corynebacterium parvum in metastatic malignant melanoma.

One hundred twenty patients with metastatic malignant melanoma were randomized to receive either cyclophosphamide, 600 mg/m2 IV, on day 1 plus DTIC 200 mg/m2 IV days 1 through 5, or the same chemotherapy plus C. parvum 5 mg/m2 IV on day 8 and day 15. Therapy was repeated every 21 days. Although responses were observed in 13.8% of patients on cyclophosphamide plus DTIC versus 25.5% of patients on cyclophosphamide plus DTIC plus C. parvum, the median duration of remission was 15.6 weeks on chemotherapy and 13.0 weeks on chemotherapy plus C. parvum. Furthermore, survival was similar on both regimens (6.1 months versus 5.7 months, respectively). Favorable prognostic factors included metastatic disease confined to skin or lymph nodes (33% responses), performance status greater than 70% (24% response rate), and administration of three or more courses of chemotherapy (31% response rate). The dose limiting toxicity was myelosuppression, which was equal on both regimens. Chills and fever were common in response to C. parvum, and, rarely hypotension, cyanosis, or immune nephritis was observed. The addition of C. parvum to chemotherapy with cyclophosphamide plus DTIC is not recommended.

Bone Marrow↗

PubMed1981

Solid tumor models for the assessment of different treatment modalities: XVI. Sequential combined modality (Cyclophosphamide-Radiation) therapy.

A tumor cure rate of 60% was realized when three series of combined radiation (1500 rads) and cyclophosphamide (150 mg/kg) doses were given sequentially to rats with hepatoma 3924A and the time between modalities held constant at 7 days. This sequence was previously shown to enhance tumor sensitivity and diminish host toxicity. The first series was given on days 0 and 7; second, days 14 and 21; and third, days 28 and 35. The cure rate was reduced to 10% when the time of the second series was increased from 14 to 32 days (first series, days 0 and 7; second, days 32 and 39; and third, days 63 and 70). No cures were obtained when the time of the second series of combined cyclophosphamide and radiation was further increased from 14 to 40 days; however, this treatment schedule resulted in at least a threefold increase in life span over controls of 30 +/- 1 days. Two and three single 1500 rad doses of radiation given 14 to 40 days apart produced skin changes within accepted limits of normal tissue tolerance. No major long-term hematological changes in peripheral blood and bone marrow have been demonstrated to date following two and three courses of cyclophosphamide given 14 to 40 days apart. Experimental results indicate that the frequency and dosage of cyclophosphamide and radiation used are within clinically acceptable doses and scheduling.

Animals↗

PubMed1981

Advanced ovarian carcinoma: a prospective and randomized clinical trial of cyclophosphamide versus combination cytotoxic chemotherapy (Hexa-CAF).

Fifty-seven evaluable patients with advanced ovarian carcinoma were randomized to receive either a combination of hexamethylmelamine, cyclophosphamide, methotrexate and 5-fluorouracil (Hexa-CAF) or high-dose cyclophosphamide alone given intravenously intermittently. Objective responses were seen in 62% of patients receiving cyclophosphamide alone, and 36% of patients in the Hexa-CAF regimen, this difference being statistically significant (P less than 0.05). The median duration of objective response (10 months vs. 9 months) and the median survival (11 months vs. 10 months) were greater in the cyclophosphamide group, but these differences were not statistically significant. It is concluded that there is no therapeutic advantage for the Hexa-CAF protocol over the alkylating agent used alone.

Adenocarcinoma, Mucinous↗

PubMed1982

A randomized comparison of cyclophosphamide, DTIC with or without piperazinedione in metastatic malignant melanoma.

One hundred and ninety-five patients with metastatic malignant melanoma were randomized to receive either cyclophosphamide 600 mg/m2 IV plus DTIC 600 mg/m2 IV day 1 (CD); or cyclophosphamide 400 mg/m2 IV, DTIC 400 mg/m2 IV, and piperazinedione 4 mg/m2 IV on day 1 (PCD). Therapy was repeated every 21 days. Patient groups were similar regarding pretreatment performance status, evaluability, and site of metastases. The overall response rate was low, 11% on CD and 12% on PCD. Paradoxically, patients with visceral disease responded at least as frequently as patients with skin and lymph node metastases only (12% and 6% respectively for CD, and 15% and 5% for PCD). Survival was identical on each treatment program, with medians of six months. The major dose-limiting toxicity was myelosuppression, which was similar on each treatment program. We conclude that the addition of piperazinedione to cyclophosphamide plus DTIC does not improve the response rate in patients with metastatic malignant melanoma. Both of the treatment programs (CD and PCD) utilizing one-day DTIC produced response rates slightly (but not meaningfully) lower than those previously obtained with cyclophosphamide plus five-day DTIC.

Antibiotics, Antineoplastic↗

PubMed1989

Combination chemotherapy and high-dose cyclophosphamide intensification for poor prognosis breast cancer. A Southwest Oncology Group Study.

Thirty-seven patients with poor prognosis, metastatic breast cancer were treated with 5-fluorouracil, vinblastine, and Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) (FUVA) induction chemotherapy. All 26 patients (74%) with responsive or stable disease after induction chemotherapy received intensification with high-dose cyclophosphamide (120 mg/kg). Continued responders received additional FUVA as consolidation. The response rate to induction therapy was 54% (with complete response [CR] in 11%). With intensification, three patients (11%) showed improved response (partial response [PR] in one, PR to complete response [CR] in two); however, six patients (23%) progressed within 2 months of cyclophosphamide intensification, three within 1 month. The overall response rate to all three phases of the study was 69%, with CR in 23%. The median survival of all patients entered in this study was 15 months. For cyclophosphamide intensification, major toxicity consisted of leukopenia with fever requiring broad-spectrum antibiotics in 27%. The authors conclude that a single cycle of high-dose cyclophosphamide intensification in metastatic breast cancer does not result in significantly improved responses or prolonged survival.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2001

Dose-escalated cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide (CHOPE) chemotherapy for patients with diffuse lymphoma: Cancer and Leukemia Group B studies 8852 and 8854.

BACKGROUND: To address the feasibility and outcome of moderate dose intensification with granulocyte-colony stimulating factor (G-CSF) for patients with aggressive non-Hodgkin lymphoma (NHL), the Cancer and Leukemia Group B (CALGB) conducted two studies evaluating dose-escalated cyclophosphamide and etoposide in the cyclophosphamide, doxorubicin, vincristine, prednisone, etoposide (CHOPE) regimen. METHODS: Eligibility criteria included histologically documented, diffuse small cleaved, diffuse mixed, diffuse large cell, or immunoblastic lymphoma, Stage III--IV or bulky Stage II disease, and an ECOG performance status of 0--1. CALGB 8852, a group-wide study, accrued 227 patients: 120 patients in the pilot study to determine the maximum tolerated dose (MTD) without G-CSF and 107 in the pilot study of dose-escalated CHOPE with G-CSF. CALGB 8854, a limited-institution, Phase I study, enrolled 38 patients and determined the MTD of CHOPE with G-CSF to be used in CALGB 8852. The MTD in both studies was defined as the dose at which 50% of patients had 1) Grade 4 neutropenia or thrombocytopenia lasting 7 days or more, or 2) Grade 3--4 hemorrhage or nonhematologic toxicity (excluding alopecia, nausea, and emesis), or 3) were prevented from receiving 100% of drug on Day 22. RESULTS: The MTD of CHOPE without G-CSF was cyclophosphamide 1000 mg/m(2) on Day 1 and etoposide 100 mg/m(2) on Days 1--3 with doxorubicin 50 mg/m(2) on Day 1, vincristine 1.4 mg/m(2) (maximum, 2 mg) on Day 1, and prednisone 100 mg on Days 1--5. With the addition of G-CSF at 200 microg/m(2) on Days 5--19, the MTD was cyclophosphamide 1500 mg/m(2) and etoposide 160 mg/m(2) on Days 1-3 with standard doses of doxorubicin, vincristine, and prednisone. Increasing the dose of G-CSF from 200 microg/m(2) to 400 microg/m(2) did not allow for further dose escalation. The primary toxicity in all cohorts was neutropenia. Four toxic deaths occurred on CALGB 8852. The 5-year failure free survival (FFS) and overall survival (OS) rates for eligible patients on CALGB 8852 were 31% (95% confidence interval [95%CI], 23--39) and 48% (95%CI, 40--57), respectively. The 5-year FFS and OS rates for eligible patients on CALGB 8854 were 34% (95%CI, 17--52) and 51% (95%CI, 33--70), respectively. CONCLUSIONS: Moderate dose escalation with G-CSF is feasible. However, response and survival rates of patients who receive dose-escalated CHOPE, even with the addition of G-CSF, appear similar to the rates reported with standard-dose CHOP.

Adult↗

PubMed2001

High-dose mitoxantrone and cyclophosphamide without stem cell support in patients with high-risk and advanced breast carcinoma: a Phase II multicentric trial.

BACKGROUND: Currently employed high-dose regimens for patients with breast carcinoma consist mainly of single-cycle combinations of alkylating agents. In a previous Phase I trial, the authors developed a tandem high-dose combination of two cycles of mitoxantrone and cyclophosphamide for the treatment of patients with metastatic breast carcinoma (MBC) and high-risk breast carcinoma (HRBC). Treatment was delivered with granulocyte-colony stimulating factor (G-CSF) but without stem cell support to avoid potential tumor cell reinfusion. The objective was to validate the safety and obtain preliminary efficacy assessment of this combination in a Phase II trial. METHODS: Fifty-three patients were included: 27 patients with MBC and 26 patients with HRBC. After standard induction treatment, patients received two cycles of mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2 separated by a 4-week interval. Patients received G-CSF and ciprofloxacin until hematologic recovery. Follow-up was performed in an outpatient setting. RESULTS: One hundred one of 106 projected cycles (95%) were delivered. The mean dose intensities achieved were mitoxantrone 5.8 mg/m2 per week and cyclophosphamide 933 mg/m2 per week. Infection developed in 46% of the cycles, and platelet transfusions were required in 42%. Nonhematologic toxicity was mainly Grade 3 emesis. There were no toxic deaths. In 17 evaluable patients with MBC, 13 patients (77%) had response improvements, including 7 complete responses (41%). CONCLUSIONS: Treatment with two cycles of mitoxantrone 25 mg/m2 and cyclophosphamide 4000 mg/m2 with G-CSF but without stem cell support was well tolerated. The dose intensities achieved approach those obtained with conventional high-dose therapy. This combination warrants further investigation as an alternative to conventional high-dose regimens.

Adult↗

PubMed2000

Cyclophosphamide versus methylprednisolone for the treatment of neuropsychiatric involvement in systemic lupus erythematosus.

BACKGROUND: Neuropsychiatric involvement in systemic lupus erythematosus is complex and several clinical presentations are related to this disease such as: convulsions, chronic headache, transverse myelitis, vascular brain disease, psychosis and neural cognitive dysfunction. OBJECTIVES: To assess the efficacy and safety of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of systemic lupus erythematosus on mortality and side effects. SEARCH STRATEGY: We searched EMBASE, LILACS, Cochrane Controlled Trials Register and MEDLINE up to and including December 1999, additional articles were sought through handsearching in relevant journals, using the search strategy described in the Cochrane Handbook [Dickersin 1994]. There were no language restrictions. SELECTION CRITERIA: All randomized controlled trials which compared cyclophosphamide to methylprednisolone were to be included. Patients of any age and gender were included if they fulfilled the criterion of the American Rheumatology Association for the diagnosis of systemic lupus erythematosus and presented with any one of the following neuropsychiatric events; convulsions, organic brain syndrome; cranial neuropathy. Outcome measures included the following: a) Overall mortality (primary event); b) Motor and psychiatric deficit (primary event); c) Clinical improvement (secondary event). DATA COLLECTION AND ANALYSIS: The analysis planned was to do the following: Data would be independently extracted by the two reviewers and cross-checked. The methodological quality of each trial would be assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, and the number of patients lost on follow-up would be recorded. The results of each RCT would be summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity would be defined by characteristics of the participants, the interventions and the outcomes. If appropriate, RCTs would be stratified based on control group and category of disease in accordance to the clinical homogeneity (external validity). The results obtained from these different methods are very similar, and therefore, only the results from the Risk Difference method, with the corresponding 95% confidence interval would be presented in this review. The fixed effects model would be used if there was no significant statistical heterogeneity. MAIN RESULTS: We found no randomised controlled trials comparing cyclophosphamide versus methylprednisolone for the treatment of neuropsychiatric involvement in the systemic lupus erythematosus. REVIEWER'S CONCLUSIONS: Cyclophosphamide regimen treatment is a form of care in neuropsychiatric involvement in systemic lupus erythematosus with no evidence to prove better effectiveness and safety when compared with methylprednisolone. This systematic review found no randomised controlled trials and its findings must be interpreted as 'no evidence of effect' and not as 'evidence of no effect'.

Antirheumatic Agents↗

PubMedDate not supplied

The effect of cyclophosphamide on B and T lymphocytes in patients with connective tissue diseases.

Absolute numbers of B (IgG-, IgM-, and IgA-staining) and T lymphocytes (sheep erythrocyte rosette-forming cells) were determined in patients with systemic lupus erythematosus and other connective tissue diseases in cyclophosphamide-treated and noncyclophosphamide-treated patients and in control subjects. In patients receiving cyclophosphamide, all three types of immunoglobulin-staining varieties of circulating B lymphocytes were significantly decreased. At the same time the circulating T lymphocytes were also significantly reduced. In patients with scleroderma treated with therapeutic doses of cyclophosphamide and studied sequentially, the reduction in B lymphocytes occurred first, with eventual depletion of both cell types. In 2 patients, an early rebound increase in T cells occurred followed by a marked reduction. These data indicate that the immunosuppressive effects of cyclophosphamide may be associated with a reduction in both cell types.

Adult↗

PubMed1988

Cyclophosphamide-induced bladder toxicity in Wegener's granulomatosis.

In a series of 111 patients with Wegener's granulomatosis who were given cyclophosphamide therapy, hemorrhagic cystitis, diagnosed on the basis of gross hematuria or at cystoscopy (or both), developed in 17 (15%). Most of these patients recovered uneventfully, with or without the discontinuation of cyclophosphamide, but 4 patients suffered a significant loss of blood, and bladder carcinoma developed in 3. New microhematuria also occurred in 52 patients (47%). The dose and duration of cyclophosphamide were greater in the group that had urotoxicity. Long-term followup of patients with hemorrhagic cystitis is mandatory for the detection of late recurrences or the development of bladder malignancy. New therapies are being directed at protecting the bladder from urotoxicity during cyclophosphamide treatment.

Administration, Oral↗

PubMed1991

Long-term preservation of renal function in patients with lupus nephritis receiving treatment that includes cyclophosphamide versus those treated with prednisone only.

The purpose of this study was to assess long-term preservation of renal function in 111 patients with systemic lupus erythematosus and active glomerulonephritis who participated in a randomized treatment trial. Four different drug treatment programs, each of which allowed the use of low-dose oral prednisone in addition to the study drug(s), were compared with a regimen consisting solely of high-dose oral prednisone. Patients randomized to receive intravenous cyclophosphamide, oral cyclophosphamide, or oral azathioprine plus cyclophosphamide had significantly better preservation of renal function than did patients who were randomized to receive prednisone only. Results in the azathioprine group did not differ from those in the prednisone-only group. Cyclophosphamide appears to have long-term benefit in the delay or prevention of end-stage renal disease in patients with lupus nephritis.

Administration, Oral↗