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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00276536

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Kidney Cancer Lymphoma Melanoma Multiple Myeloma Sarcoma Unspecified Adult Solid Tumor, Protocol Specific	Biological: recombinant interferon alpha-1b Drug: IFN	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment IFN weekly	Biological: recombinant interferon alpha-1b interferon Other Names: Interferon Drug: IFN IFN daily Other Names: Interferon

Arm

Intervention/Treatment

Experimental: Treatment

IFN weekly

Biological: recombinant interferon alpha-1b

interferon

Other Names:

Interferon

Drug: IFN

IFN daily

Other Names:

Interferon

Outcome Measures

Primary Outcome Measures

Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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