Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00276536

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00276536

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider