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Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa


Phase 2
16 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU2498

NCT ID:

NCT00049439

Start Date:

March 1998

Completion Date:

February 2008

Related Keywords:

  • Lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related lymphoblastic lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032