Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

NCT ID: NCT00276536

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2004-01-31

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.

Detailed Description

OBJECTIVES:

• Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
• Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

Breast Cancer; Kidney Cancer; Lymphoma; Melanoma; Multiple Myeloma; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

IFN weekly

Group Type: EXPERIMENTAL

recombinant interferon alpha-1b

Intervention Type: BIOLOGICAL

interferon

IFN

Intervention Type: DRUG

IFN daily

Interventions

recombinant interferon alpha-1b

interferon

Intervention Type: BIOLOGICAL

IFN

IFN daily

Intervention Type: DRUG

Other Intervention Names

Interferon; Interferon

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy, including, but not limited to, renal cell carcinoma, melanoma, Kaposi's sarcoma, breast carcinoma, lymphoma, myeloma, or tumors of endothelial origin

• Stage IV disease
• Refractory to standard therapy
• Measurable or evaluable disease

• Evaluable disease can include clinically or radiographically nonmeasurable tumor or specific tumor markers
• Patients with prior solitary CNS metastasis allowed

• Must have had prior definitive therapy ≥ 3 months previously
• No requirement for glucocorticoids unless for physiologic replacement
• No multiple CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.3 times upper limit of normal (ULN) OR
• Creatinine clearance of 60 mL/min
• Bilirubin ≤ 1.3 times ULN
• AST ≤ 5 times ULN
• No pregnant or lactating women
• Fertile women and men, unless surgically sterile, must use effective contraception
• 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 disease
• No other severe cardiovascular disease
• No known seizure disorder
• No known HIV or hepatitis B surface antigen positivity
• No active clinical infection requiring antibiotics within the past 7 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 4 months since prior interferon therapy and/or ≤ 400 million units of interferon
• At least 3 weeks since prior major surgery requiring general anesthesia
• At least 3 weeks since prior radiotherapy or chemotherapy
• Treatment with hormones or other chemotherapeutic agents may not be administered except for steroids given for preexisting adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
• No prior organ allograft
• No concurrent dexamethasone, other steroidal antiemetics, or anti-inflammatories
• No concurrent palliative radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ernest C. Borden, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-3575

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-CCF-3575

Identifier Type: -

Identifier Source: org_study_id