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Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant human stem cell factor
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation Must have had 1 of the following AIDS-defining illnesses: Opportunistic infection Opportunistic malignancy (excluding CNS involvement) CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3) Receiving antiretroviral therapy No concurrent Kaposi's sarcoma Prior Kaposi's sarcoma in complete response allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic Absolute granulocyte count greater than 1,000/mm^3* Hemoglobin at least 10 g/dL* Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts Hepatic No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices Bilirubin no greater than 2 mg/dL INR no greater than 1.5 Renal Not specified Cardiovascular No prior angioedema No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg) No unstable angina No New York Heart Association class III or IV heart disease No congestive heart failure No coronary angioplasty within the past 6 months No myocardial infarction within the past 6 months No uncontrolled atrial or ventricular cardiac arrhythmia Pulmonary No history of seasonal or recurrent asthma within the past 10 years No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection Immunologic No prior positive allergy test (skin or radioallergosorbent test) for insect venoms No known allergy to E. coli-derived products No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm Drug allergies manifested solely by rash and/or urticaria allowed No recurrent urticaria (isolated episode of urticaria allowed) No other active uncontrolled infection (including one with current symptoms of bronchoconstriction) No fever of 38.2° C or higher Fevers due to B symptoms allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior or concurrent CNS malignancy No poorly controlled diabetes No other significant nonmalignant disease No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy) PRIOR CONCURRENT THERAPY: Biologic therapy See Hematopoietic in Patient Characteristics No prior stem cell factor No concurrent interleukin-11 for thrombocytopenia Chemotherapy No concurrent chemotherapy for malignancy Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No concurrent enrollment on any other protocol utilizing an investigational drug No concurrent beta adrenergic blocking agents

Sites / Locations

  • Roswell Park Cancer Institute
  • Arthur G. James Cancer Hospital - Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
January 30, 2013
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058045
Brief Title
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
Official Title
A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy. PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.
Detailed Description
OBJECTIVES: Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies. Determine the immune status of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of stem cell factor. Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 3 patients receives treatment at the MTD. Patients are followed every 2 weeks for 1 month. PROJECTED ACCRUAL: A total of 3-18 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
Lymphoma
Keywords
AIDS-related peripheral/systemic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant human stem cell factor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation Must have had 1 of the following AIDS-defining illnesses: Opportunistic infection Opportunistic malignancy (excluding CNS involvement) CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3) Receiving antiretroviral therapy No concurrent Kaposi's sarcoma Prior Kaposi's sarcoma in complete response allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy Not specified Hematopoietic Absolute granulocyte count greater than 1,000/mm^3* Hemoglobin at least 10 g/dL* Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts Hepatic No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices Bilirubin no greater than 2 mg/dL INR no greater than 1.5 Renal Not specified Cardiovascular No prior angioedema No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg) No unstable angina No New York Heart Association class III or IV heart disease No congestive heart failure No coronary angioplasty within the past 6 months No myocardial infarction within the past 6 months No uncontrolled atrial or ventricular cardiac arrhythmia Pulmonary No history of seasonal or recurrent asthma within the past 10 years No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection Immunologic No prior positive allergy test (skin or radioallergosorbent test) for insect venoms No known allergy to E. coli-derived products No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm Drug allergies manifested solely by rash and/or urticaria allowed No recurrent urticaria (isolated episode of urticaria allowed) No other active uncontrolled infection (including one with current symptoms of bronchoconstriction) No fever of 38.2° C or higher Fevers due to B symptoms allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior or concurrent CNS malignancy No poorly controlled diabetes No other significant nonmalignant disease No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy) PRIOR CONCURRENT THERAPY: Biologic therapy See Hematopoietic in Patient Characteristics No prior stem cell factor No concurrent interleukin-11 for thrombocytopenia Chemotherapy No concurrent chemotherapy for malignancy Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No concurrent enrollment on any other protocol utilizing an investigational drug No concurrent beta adrenergic blocking agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zale P. Bernstein, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer

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