NCT00058045

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

April 7, 2003

Last Update Submit

January 30, 2013

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphoma

Interventions

aldesleukinBIOLOGICAL
recombinant human stem cell factorBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

aldesleukinStem Cell Factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Zale P. Bernstein, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

August 1, 2002

Primary Completion

November 1, 2003

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(2)