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

Breast Cancer Clinical Trial

— IFNa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276536
• Other study ID #: CASE-CCF-3575
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2006
• Last updated: October 11, 2015
• Start date: January 2001
• Est. completion date: January 2004

Study information

• Verified date: October 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• recombinant interferon alpha-1b
interferon

Drug:
• IFN
IFN daily

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes