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PubMed1997

Perivascular and intralesional tissue necrosis after hepatic cryoablation: results in a porcine model.

BACKGROUND: Cryosurgical ablation of malignant hepatic tumors is being increasingly used for definitive treatment of metastatic colorectal and primary hepatic tumors. The lack of tumor necrosis near vessels that results from inadequate freezing may contribute to local recurrence and thus limit the applications of this therapy. This study was designed to determine whether single-freeze cryoablation could cause necrosis of both the pervascular and intralesional hepatic parenchyma. METHODS: Ten pigs were treated with one 15-minute cycle of cryoablation. Five additional animals were treated with overlapping cryolesions to simulate a double freeze. After 24 hours, animals underwent reoperation with portal vein cannulation and infusion of formalin. Serial sectioning and hematoxylin and eosin staining of cryolesions were performed. RESULTS: Complete cell death was visualized within all cryolesions. There was no difference between once or twice-frozen tissue. Vessels within or adjacent to cryolesions showed necrosis of hepatic tissue up to the vessel wall. No sections revealed incomplete necrosis of perivascular hepatic parenchyma. CONCLUSIONS: Single-freeze cryoablation results in necrosis of intralesional hepatic parenchyma without added benefit from repeat freezing. Complete necrosis of the perivascular tissue suggests that cryosurgical ablation can effectively cause necrosis immediately adjacent to vessels without concerns of incomplete ablation resulting from the heat sink effect.

Animals↗
PubMed1986

Intravenous, intralesional and endolymphatic administration of lymphokines in human cancer.

Starting in 1976 we have given two types of lymphokine preparation to 78 individual patients with cancer with no evidence of long-term toxicity. Lymphokine from the 1788 lymphoblastoid line (1788-LK) was given intravenously and intralesionally to 39 of these patients and buffy coat interleukin (BC-IL) to 40 of the patients. On intravenous injection both preparations produced pyrexia and other acute phase changes but with an earlier time course after BC-IL. Feelings of well-being were volunteered and the patients often remained in a steady clinical state for a long time when previously their condition had been deteriorating. Histological studies after intralesional injection into recurrent breast nodules (1788-LK and BC-IL) and prostate (1788-LK) showed an inflammatory cell infiltrate and tumour cell necrosis. Endolymphatic infusion of BC-IL in 23 patients with malignant melanoma was followed by clinical, radiological and histological evidence of lymph node activation. 10 of these patients had had excision of poor prognosis primary tumour only and during the follow-up period (5-17 months) none had a recurrence. Our experience suggests that administration of lymphokines has a place in the total management of cancer patients.

Breast Neoplasms↗
PubMed1999

Enhanced tumor targeting by an intratumoral injection of colloidal chromic 32P in two human tumors (AsPC-1 pancreas and Ls174T colon) in nude mice.

BACKGROUND AND OBJECTIVES: To find the mechanisms of the ongoing clinical trials in intralesional colloidal chromic 32P (32P-CP) brachytherapy, the cellular uptake of 32P-CP, changes in tumor interstitial fluid pressure (TIFP), and tumor blood flow (TBF) using two (AsPC-1, Ls174T) human tumors were measured. METHODS: After exposure to 32p-CP using exponential and plateau-phase cells, cells were trypsinized at various time intervals, then measured for the levels of radioactivity using a y-counter. Also measured were TIFP using the WIN technique and TBF with laser Doppler flowmetry. RESULTS: The plateau growth-phase of both tumors showed the maximal uptake of 32P-CP at approximately 100 min. TBF decreased within 10 min after an intratumoral (i.t.) injection of 32P-CP, and reached 75% of control value by 1 h. CONCLUSIONS: If 32P-CP was introduced i.t., it maintained highly efficient tumor targeting, mainly due to two physiological mechanisms: the high adherence of 32P-CP to the infused regions and the reduction in TBF by this therapeutic colloid.

Adenocarcinoma↗
PubMed1999

The effect of various therapeutic solutions including colloidal chromic 32P via an intratumoral injection on the tumor physiological parameters of AsPC-1 human pancreatic tumor xenografts in nude mice.

To overcome the physiological barrier in solid tumors (i.e., tumor hypertension), a large volume of material is required via an intratumoral injection. Alternatively, a method of reduction in tumor hypertension is also feasible. In this study, we focused on the physiological response after an intratumoral infusion of various therapeutic agents. Tumor interstitial fluid pressure (TIFP) was intermittently monitored for up to 7 days after treatment using AsPC-1 human pancreatic tumors in nude mice. Macroaggregated albumin (MAA), colloidal chromic 32P (32P-CP), albumin, dexamethasone, 5-fluoro-2'deoxyuridine, dextrose, saline, and trypan blue increased TIFP within approximately 5 min, and TIFP returned to the original level within 1 h, except in the case of MAA and 32P-CP. We also found that the maximal uptake for AsPC-1 tumors in both the exponential and plateau growth phases occurred at approximately 100 min postincubation; the maximum value in the exponential growth phase was approximately 2 times less than that of plateau growth phase (P < 0.01). Therefore, this study supports intralesional 32P-CP brachytherapy for nonresectional pancreatic cancer patients. This may offer a promising treatment modality for delivering high doses of tumor-selective radiation, mainly due to two physiological mechanisms: (a) the high adherence of 32P-CP to the infused regions; and (b) reduction in either tumor blood flow or TIFP by this therapeutic colloid.

Animals↗
PubMed1996

Hexafluorobenzene: a sensitive 19F NMR indicator of tumor oxygenation.

We have surveyed the sensitivity of the spin lattice relaxation rates of the 19F resonances of several perfluorocarbons to changes in oxygen tension and temperature. Hexafluorobenzene was found to exhibit exceptional sensitivity to changes in oxygen tension, and we have exploited this phenomenon to measure tumor oxygen tension following intratumoral injection. When 20 microliters hexaflourobenzene were injected they remained localized and the biodistribution was readily assessed on the basis of combined 1H and 19F three-dimensional MRI. Relaxation measurements indicated a typical baseline oxygen tension of 4.0 +/- 1.5 torr in the central region of a Dunning prostate R3327-AT1 tumor when the rat breathed 66% oxygen. Altering the inspired oxygen concentration to 100% produced a modest increase in pO2 (5.6 +/- 0.7 torr; p < 0.1). Significantly, the precision of these measurements should facilitate NMR investigations of radiobiological hypoxia. Intra-tumoral injection allowed measurements from regions not normally accessible to infused perfluorocarbons and provides an additional approach to measuring tumor oxygenation.

Adenocarcinoma↗
PubMed2004

Long term survival in a patient with recurrent malignant glioma treated with intratumoral infusion of an IL4-targeted toxin (NBI-3001).

Intratumoral infusion of a recombinant targeted toxin (NBI-3001) consisting of the receptor binding domain of human interleukin 4 (IL-4) and Pseudomonas aeruginosa exotoxin A is an investigational treatment for malignant brain tumors. This 27-year-old male patient presented with a recurrent malignant glioma WHO grade IV after surgery and adjuvant radiation and chemotherapy. The recurrence was treated with intratumoral infusion of NBI-3001 at a dose of 9 microg/ml in 66 ml of infusate. Treatment resulted in long-term survival for 3 years after toxin infusion with a durable tumor response. There were some permanent neurological side effects resulting from toxin infusion. The patient eventually died after a late local recurrence of the known brain tumor. Such clinical evolution of a malignant glioma after a single round of immunotoxin infusion is rather unusual. The late local recurrence may suggest that repeated courses rather than a single infusion of intratumoral toxin are possibly needed for successful long-term tumor control.

Adult↗
PubMed1997

The role of interleukin-2, interleukin-12, and dendritic cells in cancer therapy.

PURPOSE: Recombinant interleukin-2 (rIL-2) administration can mediate regression of solid tumors in patients with melanoma and renal cell carcinoma. A better understanding of the mechanisms of rIL-2-mediated antitumor effects has led to the investigation of novel immunotherapeutic approaches. Two approaches that appear promising include administration of antigen-pulsed dendritic cells (DC) and administration of DC or genetically engineered fibroblasts expressing human interleukin-12 (IL-12). The rationale for these immunotherapeutic approaches and preliminary clinical studies are presented. PATIENTS AND METHODS: We have conducted a pilot study to evaluate the feasibility of treating melanoma patients with peptide-pulsed DC. Six melanoma patients received 1 to 3 x 10(6) DC pulsed with synthetic melanoma antigenic peptides. The peptide-pulsed DC were infused weekly for 4 weeks. We have also treated 32 patients in a phase I/II trial with IL-12-producing fibroblasts. Patients received escalating doses of cells weekly for 4 weeks, which produced quantities of IL-12 ranging from 10 ng to 9 micrograms/24 hours. RESULTS: Infusion of melanoma peptide-pulsed DC produced a complete response in one patient, and significant T-cell and DC infiltration of melanoma lesions was observed. Lesional and regional responses have been observed in patients with melanoma, head and neck carcinoma, and breast cancer who received intralesional injections of IL-12-producing fibroblasts. Phase II studies of this approach are planned and will be initiated in the next few months. CONCLUSIONS: These studies confirm the feasibility of these novel immunotherapeutic approaches and demonstrate their potential antitumor activity. These approaches may be effective in patients with metastatic melanoma and other solid tumors, and they may ultimately be used to improve the efficacy of rIL-2-based immunotherapy.

Carcinoma, Renal Cell↗
PubMed1994

[An experimental study on radiotherapy for esophageal cancer using intraluminal administration of radiosensitizer].

This study was undertaken to evaluate the efficacy of intraluminal administration of 5-bromo-2'-deoxyuridine (BUdR) as a radiosensitizer during radiotherapy for esophageal cancer. Lipid-surfactant mixed micelles (MM) was used as an absorption promoter. VX2 carcinoma cells were endoscopically injected into the esophageal wall of rabbits. Two weeks after tumor inoculation, BUdR (100 mg/body) with MM was administered into the esophageal lumen and kept for 3 hours. Subsequently, animals were irradiated with 60Co at dosages of either 5 or 10 Gy. Twelve days after, animals were sacrificed to determine tumor diameter and to evaluate histological effect of radiation. BUdR uptake rates of tumor tissue were determined two weeks after tumor inoculation. Tumor diameters in control animals and those treated with simple irradiation at a dose of 5 Gy were similar. In contrast, irradiation at a dose of 5 Gy significantly reduced tumor diameters when combined with intraluminal administration of BUdR with MM. In cancer bearing animals receiving irradiation under intraluminal injection of BUdR with MM, the histological effect were apparently enhanced as compared to animals receiving simple irradiation. BUdR uptake rates of primary tumors showed a significant increase in animals with the intraluminal administration of the drug as compared the those with intravenous one shot bolus and intravenous drip infusion. Based on those results, we conclude that preoperative radiotherapy combined with intraluminal administration of radiosensitizer could be an effective method.

Animals↗
PubMed1997

Intralesionally implanted cisplatin cures primary brain tumor in rats.

BACKGROUND AND OBJECTIVES: Chemotherapy has added little to the overall survival of the patients with primary malignant brain tumors, primarily due to its difficulty penetrating the blood-brain barrier. Use of polymers, releasing high doses of chemotherapy locally over time, is a promising new treatment strategy. Three experiments were conducted to test the effect of cisplatin, released from biodegradable polymer, on rats with 1 week established brain tumor. METHODS: 9L gliosarcoma cells and drug-free or cisplatin-loaded polymer were administered through a right frontal lobe cannula in male Fischer 344 rats. Tumor cells were infused on day 0 and polymer on day 7. Animals were monitored for 60 days. RESULTS: In experiment one, 0.5 mg/m2 of cisplatin loaded in polymer resulted in a mean survival time (MST) of 51 +/- 14 days with 63% (10/16) rats surviving to day 60. MST for the control group was 24 +/- 4 days (p = 2.5 x 10(-9)). Evidence of clinical or histologic brain toxicity was minimal. In a second experiment, using drug-free polymer (n = 7), MST was 24 +/- 3 days. This was compared against an MST of 24 +/- 4 days in the tumor control group (n = 7) and 49 +/- 7 days in a cisplatin-polymer treated group (n = 6). In a third experiment, two doses of drug-free polymer and three doses of cisplatin-loaded polymer were tested in normal nontumor-bearing rats and found to be well tolerated. CONCLUSIONS: Intralesional sustained release of cisplatin from biodegradable polymer is safe and effective for the treatment of brain 9L gliosarcoma in rats.

Animals↗
PubMed1984

The clinical application of fibroblast interferon--an overview.

Preclinical as well as clinical studies with fibroblast interferon (IFN) are still lagging behind on those with leukocyte interferon. Its side-effects seem to be less pronounced than those of human IFN-alpha, yet it may be slightly pyrogenic after intravenous injection. Pyrogenicity of current impure preparations might for the larger part be due to impurities. Higher doses of HuIFN-beta than of HuIFN-alpha are required to obtain measurable blood titers by intramuscular injections. Since there is concern about this being due to destruction of the interferon before it has reached its target organ(s), most current clinical studies use either local (e.g. intratumoral) treatment or intravenous infusions. A study of topical treatment for acute rhinovirus infection has indicated that there is very little if any chance for fibroblast interferon to be a clinically useful substance to prevent or cure common cold. In herpetic dendritic keratitis eye drops of fibroblast interferon may be useful as such or in combination with debridement. Topical treatment of warts (multiple intralesional injections) has been shown to yield a high success rate, especially in the case of verrucae vulgares, but less so in the case of verrucae planae juveniles. Studies on condyloma accuminatum are not so far advanced as to permit a documented conclusion. Topical (intralesional) treatment of neoplastic diseases has been investigated, especially in Japan, to demonstrate that fibroblast interferon does have an antineoplastic effect in vivo. While there seems to be little doubt that local delivery does indeed cause tumor nodules to regress, the question is whether this procedure can offer a true clinical benefit to the patient. Systemic (intravenous) administration for chronic hepatitis B has been investigated further: given alone or in combination with adenine-arabinoside, fibroblast interferon seems to be able to reduce the level of viral activity. Whether this will lead to a generally accepted treatment of chronic active hepatitis is difficult to say at this moment. In treating herpes zoster in cancer patients, results have been obtained which are comparable to those found for leukocyte interferon. The practical significance of this finding must be seen in the perspective of recent developments in the chemotherapy of herpes zoster. In breast cancer patients given intramuscular injections, metastases in the skin, but not in other organs, showed alterations suggestive of an effect on tumor progression. Yet there was no true clinical benefit for the patient. In other tumors, e.g. head and neck epithelioma, no effect was seen.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Topical↗
PubMed2000

Cloning and neuronal expression of a type III newt neuregulin and rescue of denervated, nerve-dependent newt limb blastemas by rhGGF2.

Urodele amphibians are the only vertebrates that can regenerate their limbs throughout their life. The critical feature of limb regeneration is the formation of a blastema, a process that requires an intact nerve supply. Nerves appear to provide an unidentified factor, known as the neurotrophic factor (NTF), which stimulates cycling of blastema cells. One candidate NTF is glial growth factor (GGF), a member of the neuregulin (NRG) growth factor family. NRGs are both survival factors and mitogens to glial cells, including Schwann cells. All forms of NRGs contain an EGF-like domain that is sufficient to activate NRG receptors erbB2, erbB3, and erbB4. To investigate the involvement of neuregulin in newt limb regeneration, we cloned and characterized one neuregulin isoform, a neuregulin with a cysteine-rich domain (CRD-NRG), from newt (Notophthalmus viridescens) spinal cord. Results of in situ hybridization showed that the newt CRD-NRG is highly expressed in dorsal root ganglia and spinal cord neurons that innervate the limbs. We also demonstrated the biological activity of recombinant human GGF2 (rhGGF2) in urodele limb regeneration. When rhGGF2 was injected into denervated, nerve-dependent axolotl blastemas, the labeling index (LI) of blastema cells was maintained at a level near to that of control, innervated blastemas, whereas without rhGGF2 the LI decreased significantly. In another experiment, rhGGF2 was delivered into denervated, nerve-dependent blastemas either by direct infusion into blastemas or by injection into the intraperitoneal cavity. The denervated blastemas were rescued into a regeneration response.

Ambystoma mexicanum↗
PubMed2004

Saline infusion sonohysterography.

Saline infusion sonohysterography consists of ultrasonographic imaging of the uterus and uterocervical cavity, using real-time ultrasonography during injection of sterile saline into the uterus. When properly performed, saline infusion sonohysterography can provide information about the uterus and endometrium. The most common indication for sonohysterography is abnormal uterine bleeding. sonohysterography should not be performed in a woman who is pregnant or could be pregnant or in a woman with a pelvic infection or unexplained pelvic tenderness. Physicians who perform or supervise diagnostic saline infusion sonohysterograpy should have training, experience, and demonstrated competence in gynecologic ultrasonography and saline infusion sonohysterography. Portions of this document were developed jointly with the American College of Radiology and the American Institute of Ultrasound in Medicine.

Antibiotic Prophylaxis↗
PubMed2003

ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography.

Saline infusion sonohysterography consists of ultrasonographic imaging of the uterus and uterocervical cavity, using real-time ultrasonography during injection of sterile saline into the uterus. When properly performed, saline infusion sonohysterography can provide information about the uterus and endometrium. The most common indication for sonohysterography is abnormal uterine bleeding. Sonohysterography should not be performed in a woman who is pregnant or who could be pregnant or in a woman with a pelvic infection or unexplained pelvic tenderness. Physicians who perform or supervise diagnostic saline infusion sonohysterography should have training, experience, and demonstrated competence in gynecologic ultrasonography and saline infusion sonohysterography. Portions of this document were developed jointly with the American College of Radiology and the American Institute of Ultrasound in Medicine.

Endosonography↗
PubMed1991

[Clinical studies of 16 cases of carcinomatous pericarditis].

We studied the effects of local therapy on cardiac tamponade caused by carcinomatous pericarditis in 16 cases. Five out of 16 cases (drainage group) received treatment by only drainage of pericardial effusion, and the remaining 11 cases (infusion group) had local infusion of antineoplastic agents into the pericardium after drainage. The median survival time was 16 weeks in the infusion group and 19 weeks in the drainage group. There was no statistically significant difference. Reaccumulation of pericardial effusion was recognized in 3 patients in the drainage group (60%), and in 3 patients in the infusion group (18%). Our conclusion was that local infusion had no effect on prolongation of the survival time, but had a suppressive effect on reaccumulation of pericardial effusion.

Antineoplastic Agents↗
PubMed1985

Treatment of metastatic malignant melanoma with intensive melphalan and autologous bone marrow transplantation.

Twenty patients with metastatic malignant melanoma were treated with melphalan (180-225 mg/m2 iv over 3 days) followed by re-infusion of previously harvested and cryopreserved autologous bone marrow. Granulocyte (greater than 500/microliter) and platelet (greater than 20,000/microliter) count recovery occurred a median of 14 days (range, 12-22) and 19.0 days (range, 12-28) after bone marrow transplantation, respectively. Three patients died due to hemorrhage or infection. One of these patients and another (who ultimately achieved a complete response), both with brain metastases, developed intralesional hemorrhage when the platelet count was only moderately reduced. Complete responses occurred in six patients and ranged from 4 to 14 months, with a median of 5 months. Six patients achieved a partial remission lasting 2-5 months. High-dose melphalan and autologous bone marrow transplantation are a promising therapy for patients with metastatic malignant melanoma.

Adult↗
PubMed1999

CTLA4Ig-mediated blockade of T-cell costimulation in patients with psoriasis vulgaris.

Engagement of the B7 family of molecules on antigen-presenting cells with their T cell-associated ligands, CD28 and CD152 (cytotoxic T lymphocyte-associated antigen-4 [CTLA-4]), provides a pivotal costimulatory signal in T-cell activation. We investigated the role of the CD28/CD152 pathway in psoriasis in a 26-week, phase I, open-label dose-escalation study. The importance of this pathway in the generation of humoral immune responses to T cell-dependent neoantigens, bacteriophage phiX174 and keyhole limpet hemocyanin, was also evaluated. Forty-three patients with stable psoriasis vulgaris received 4 infusions of the soluble chimeric protein CTLA4Ig (BMS-188667). Forty-six percent of all study patients achieved a 50% or greater sustained improvement in clinical disease activity, with progressively greater effects observed in the highest-dosing cohorts. Improvement in these patients was associated with quantitative reduction in epidermal hyperplasia, which correlated with quantitative reduction in skin-infiltrating T cells. No markedly increased rate of intralesional T-cell apoptosis was identified, suggesting that the decreased number of lesional T cells was probably likely attributable to an inhibition of T-cell proliferation, T-cell recruitment, and/or apoptosis of antigen-specific T cells at extralesional sites. Altered antibody responses to T cell-dependent neoantigens were observed, but immunologic tolerance to these antigens was not demonstrated. This study illustrates the importance of the CD28/CD152 pathway in the pathogenesis of psoriasis and suggests a potential therapeutic use for this novel immunomodulatory approach in an array of T cell-mediated diseases.

Abatacept↗