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| Sponsor: | Cancer Biotherapy Research Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002733 |
Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: therapeutic tumor infiltrating lymphocytes Drug: cimetidine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 1996 |
OBJECTIVES: I. Determine the response rate and failure-free survival in patients with metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II. Describe the toxic effects and costs associated with this therapy to assess risk benefit and cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.
OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion. Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologic evidence of any type of cancer with metastases Melanoma or renal cell cancer preferred No active brain metastasis Tumor infiltrating lymphocytes must be available Measurable or evaluable disease preferred
PATIENT CHARACTERISTICS: Age: 18 and over (under 75 preferred) Performance status: ECOG 0-3 (ECOG 0 or 1 preferred) Hematopoietic: (preferred) WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) Hepatic: (preferred) Bilirubin less than 2.0 mg/dL PT/PTT normal Renal: (preferred) Creatinine less than 2.0 mg/dL Cardiovascular: (preferred) At least 6 months since prior myocardial infarction No congestive heart failure, cardiac arrhythmia, or hypertension requiring medication Pulmonary: (preferred) pO2 at least 60 mm Hg Reasonable respiratory reserve No supplemental oxygen requirement Not dyspneic at rest Other: No chronic auto-coagulation (preferred) No active infection No chronic underlying immunodeficiency disease (including HIV, hepatitis B) No known autoimmune disease Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (7 days since stereotactic radiosurgery) Surgery: At least 4 weeks since prior surgery to control brain metastases No prior organ transplantation
Contacts and Locations| United States, California | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
More Information
| Study ID Numbers: | CDR0000064631, CBRG-9510, NBSG-9510, NCI-V96-0835 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002733 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer stage IV melanoma unspecified adult solid tumor, protocol specific |
|
Anti-Infective Agents Neurotransmitter Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms |
Therapeutic Uses Neoplasms, Germ Cell and Embryonal Anti-Ulcer Agents Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Cimetidine Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Gastrointestinal Agents Histamine Agents |
