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

Primary Purpose

Breast Cancer, Kidney Cancer, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alpha-1b
IFN
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV melanoma, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

IFN weekly

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
October 11, 2015
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276536
Brief Title
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
Acronym
IFNa
Official Title
Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
stage IV melanoma, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
IFN weekly
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alpha-1b
Other Intervention Name(s)
Interferon
Intervention Description
interferon
Intervention Type
Drug
Intervention Name(s)
IFN
Other Intervention Name(s)
Interferon
Intervention Description
IFN daily
Primary Outcome Measure Information:
Title
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
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest C. Borden, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5044
Country
United States

12. IPD Sharing Statement

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

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