NCT00049439

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_2 lymphoma

Geographic Reach
3 countries

4 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

March 1, 1998

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

7.6 years

First QC Date

November 12, 2002

Last Update Submit

June 9, 2010

Conditions

Lymphoma

Keywords

AIDS-related diffuse large cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related lymphoblastic lymphomaAIDS-related small noncleaved cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Disease response

    Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Secondary Outcomes (1)

  • Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory

    days 1 and 2 of courses 1 and 2 and on day 84

Interventions

filgrastimBIOLOGICAL

filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

cyclophosphamideDRUG

Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

etoposideDRUG

Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

lomustineDRUG

Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

procarbazine hydrochlorideDRUG

Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of acquired immune deficiency syndrome * Histologically confirmed stage I, II, III, or IV intermediate- or high-grade non-Hodgkin's lymphoma * B-cell, T-cell, or indeterminate immunologic phenotype * Measurable or evaluable disease * No clinical, radiographic, or cytological evidence of CNS parenchymal, vitreal, or leptomeningeal involvement by lymphoma NOTE: 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 and over (in the United States) * 16 and over (in Africa) Performance status * ECOG 0-3 Life expectancy * At least 6 weeks Hematopoietic * WBC at least 1,500/mm3 * Platelet count at least 50,000/mm3 Hepatic * Bilirubin no greater than 3.0 mg/dL Renal * Creatinine no greater than 3.0 mg/dL Other * Concurrent active infection for which patient is receiving treatment allowed provided clinical status is stable * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for lymphoma Endocrine therapy * Not specified Radiotherapy * Prior radiotherapy for stage I or II disease allowed provided there is documentation of disease progression Surgery * Not specified Other * Concurrent antiretroviral therapy (except zidovudine) allowed

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

Sponsors & Collaborators

Study Sites (4)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University of Nairobi College of Health Sciences

Nairobi, Kenya

Location

Uganda Cancer Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Lymphoma

Interventions

FilgrastimCyclophosphamideEtoposideLomustineProcarbazine

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 FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesNitrosourea CompoundsUreaAmidesNitroso CompoundsBenzamidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene Derivatives

Study Officials

  • Scot C. Remick, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

March 1, 1998

Primary Completion

October 1, 2005

Study Completion

February 1, 2008

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

UG(1)US(2)KE(1)