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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058045
• Other study ID #: RP 99-11
• Secondary ID: RPCI-RP-9911
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2003
• Last updated: January 30, 2013
• Start date: August 2002

Study information

• Verified date: January 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• aldesleukin

• recombinant human stem cell factor

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,