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Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00049439   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes

November 12, 2002
February 6, 2009
March 1998
 
  • Disease response after course 2 and then every 3 months [ Designated as safety issue: No ]
  • Survival every 3 months [ Designated as safety issue: No ]
  • Toxicity as assessed by physical exam and laboratory tests on days 1 and 22 of courses 1 and 2 and on day 84 [ Designated as safety issue: Yes ]
  • Disease response after course 2 and then every 3 months
  • Survival every 3 months
  • Toxicity as assessed by physical exam and laboratory tests on days 1 and 22 of courses 1 and 2 and on day 84
Complete list of historical versions of study NCT00049439 on ClinicalTrials.gov Archive Site
Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory on days 1 and 2 of courses 1 and 2 and on day 84 [ Designated as safety issue: No ]
Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory on days 1 and 2 of courses 1 and 2 and on day 84
 
Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa

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.

OBJECTIVES:

  • Determine the objective response rate, response duration, and survival of patients with AIDS-related non-Hodgkin's lymphoma treated with lomustine, etoposide, cyclophosphamide, and procarbazine.
  • Determine the feasibility of this regimen in these patients.
  • Determine the clinical toxicity of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.
  • Determine the impact of this regimen on the underlying HIV infection in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral lomustine on day 1 (course 1 only), oral etoposide on days 1-3, and oral cyclophosphamide and oral procarbazine on days 22-26. Patients may also receive 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.

Quality of life is assessed at baseline, on days 1 and 22 of each course, at day 84, and then every 3 months for 1 year.

Patients are followed at day 84 and then every 3 months.

PROJECTED ACCRUAL: A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: lomustine
  • Drug: procarbazine hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Kenya,   Uganda
 
NCT00049439
 
CDR0000258098, CWRU-029828J, CWRU-2498, NCI-G02-2126, CASE-2498
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP