NCT00003575

Brief Summary

Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 lymphoma

Geographic Reach
1 country

10 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

February 8, 2013

Status Verified

October 1, 2002

Enrollment Period

3.2 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphomaAIDS-related diffuse large cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related small noncleaved cell lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study.

Biological: filgrastimBiological: recombinant interleukin-12Drug: etoposideDrug: ifosfamide

Interventions

filgrastimBIOLOGICAL
Arm I
recombinant interleukin-12BIOLOGICAL
Arm I
etoposideDRUG
Arm I
ifosfamideDRUG
Arm I

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * HIV-infected patients with histologically or cytologically proven intermediate grade large cell lymphoma; high grade large cell immunoblastic lymphoma; or high grade small noncleaved cell lymphoma who have either failed to respond to or relapsed following first line combination chemotherapy * Bidimensionally measurable disease * No CNS lymphoma (parenchymal brain or spinal cord tumor) * No meningeal lymphoma * A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Age: 18 to 70 * Performance status: Karnofsky 60-100% * Absolute neutrophil count at least 1,000/mm3 * Platelet count greater than 75,000/mm3 * Hematologic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver * Bilirubin less than 2.0 mg/dL, except in patients receiving indinavir who have isolated hyperbilirubinemia * Transaminases less than 5 times upper limit of normal * Hepatic criteria not applicable if abnormal functions are attributable to lymphomatous infiltration of bone marrow or liver * Creatinine clearance greater than 60 mL/min * No other prior or concurrent malignancy except carcinoma in situ of the cervix or nonmetastatic nonmelanomatous skin cancer * No acute active opportunistic infection requiring antibiotic treatment Patients with Mycobacterium avium complex allowed * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior immunomodulating agents * Concurrent filgrastim (G-CSF) allowed * Concurrent epoetin alfa allowed * Concurrent antibiotics may be given if clinically indicated during study * No more than 2 prior standard treatment regimens for non-Hodgkin's lymphoma * No concurrent systemic corticosteroids * Concurrent topical and/or oral antifungal agents permitted

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

Sponsors & Collaborators

Study Sites (10)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

San Francisco General Hospital Medical Center

San Francisco, California, 94110, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2617, United States

Location

University Hospital/New Jersey Cancer Center

Newark, New Jersey, 07103, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

FilgrastimInterleukin-12 Subunit p35EtoposideIfosfamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsInterleukin-12InterleukinsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lawrence D. Kaplan, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 20, 2004

Study Start

January 1, 1999

Primary Completion

April 1, 2002

Last Updated

February 8, 2013

Record last verified: 2002-10

Locations

US(10)