Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
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Purpose
This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Melanoma (Skin) |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma |
| Enrollment: | 30 |
| Study Start Date: | March 2000 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above. |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
|
Experimental: Arm II
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above. |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
|
Experimental: Arm III
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above. |
Biological: recombinant interferon alfa Biological: recombinant interleukin-12 |
Detailed Description:
OBJECTIVES:
I. Determine the toxicity of interleukin-12 and interferon alfa in patients with metastatic renal cell carcinoma or malignant melanoma.
II. Determine the maximum tolerated dose of these drugs when concurrently administered in this patient population.
III. Obtain preliminary data on the antitumor efficacy of this combination in these patients.
OUTLINE: This is a dose-escalation study, followed by a randomized study.
Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Once the MTD is established, additional patients are accrued and randomized to 1 of the following treatment arms:
ARM I: Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
ARM II: Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
ARM III: Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for the dose escalation portion of this study. An additional 18 patients (5 in arm I, 5 in arm II, and 8 in arm III) will be accrued to the randomized portion of this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma or malignant melanoma
- Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
- Bidimensionally measurable of evaluable disease
- No significant effusions and/or ascites
- No more than 3 prior regimens for metastatic disease
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.5 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT/AST no greater than 3 times upper limit of normal
Renal:
- Creatinine no greater than 1.8 mg/dL
- Calcium no greater than 11.5 mg/dL
Cardiovascular:
- No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- No congestive heart failure
- No angina pectoris
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active peptic ulcer
- No autoimmune disease
- No inflammatory bowel disease
- No local or systemic infections requiring IV antibiotics within the past 28 days
- No known seizure disorder
- No other prior malignancy except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any curatively treated malignancy in complete remission for at least 3 years
- HIV, hepatitis B surface antigen, and hepatitis C negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior biologic therapy
Chemotherapy:
- Recovered from prior chemotherapy
Endocrine therapy:
- At least 28 days since prior hormonal therapy and recovered
- No concurrent corticosteroids except for replacement steroids
Radiotherapy:
- Recovered from prior radiotherapy
- At least 28 days since prior radiotherapy for control of pain from skeletal lesions
Surgery:
- At least 28 days since prior major surgery requiring general anesthesia
- No organ allografts
Other:
- No concurrent aspirin
- No concurrent barbiturates
- No other concurrent investigational agents
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004244 History of Changes |
| Other Study ID Numbers: | CDR0000067489, CCF-IRB-3063, NCI-T99-0028 |
| Study First Received: | January 28, 2000 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
stage IV renal cell cancer recurrent renal cell cancer stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Melanoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferons Interleukin-12 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 19, 2013