Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma

NCT00004244 | Completed Phase 1

• 3 other identifiers: CDR0000067489CCF-IRB-3063NCI-T99-0028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer; Melanoma (Skin)

Keywords

stage IV renal cell cancer; recurrent renal cell cancer; stage IV melanoma; recurrent melanoma

Study Arms (3)

Arm I

EXPERIMENTAL

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

Arm II

EXPERIMENTAL

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

Arm III

EXPERIMENTAL

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

Interventions

recombinant interferon alfa BIOLOGICAL

Arm I; Arm II; Arm III

recombinant interleukin-12 BIOLOGICAL

Arm I; Arm II; Arm III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Carcinoma, Renal Cell

Interventions

Interferon-alpha; Interleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukin-12; Interleukins

Study Officials

• Ronald M. Bukowski, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: January 27, 2003
• Study Start: March 1, 2000
• Primary Completion: July 1, 2005
• Study Completion: September 1, 2008
• Last Updated: March 21, 2013

Record last verified: 2005-06

Locations

US (1)