Clinical trial NCT00005824: Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma
Official title: Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
HIV-associated Hodgkin lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma.

Detailed description: OBJECTIVES:

* Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma.
* Determine the response and response duration in these patients treated with this regimen.
* Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients.

OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood counts recover. Patients then undergo leukopheresis to collect CD34+ cells.

Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover.

Patients are followed monthly for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease

  * Failed to achieve complete remission with initial therapy OR
  * Relapsed after initial therapy
* May be in complete remission after salvage therapy
* Sensitive to most recent chemotherapy

  * Improvement of at least 25% in bidimensional tumor measurements OR
  * Improvement in evaluable disease sustained over 4 weeks
* Measurable or evaluable disease
* HIV-1 positive
* CD4 greater than 50 cells/mm\^3 (unless not receiving optimal antiretroviral therapy)
* HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy)
* No active leptomeningeal or parenchymal CNS involvement 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:

* Physiologic 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3

Hepatic:

* AST no greater than 3 times upper limit of normal
* Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir)

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No history of cardiac disease
* LVEF at least 45%

Pulmonary:

* No history of symptomatic pulmonary disease
* DLCO at least 60%

Other:

* No active opportunistic infections
* No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy
* No sensitivity to E. coli-derived products
* Not pregnant
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 1 week since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Chronic suppressive therapy for infection allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David T. Scadden, MD
role: STUDY_CHAIR
References:
citation: Spitzer TR, Ambinder RF, Lee JY, Kaplan LD, Wachsman W, Straus DJ, Aboulafia DM, Scadden DT. Dose-reduced busulfan, cyclophosphamide, and autologous stem cell transplantation for human immunodeficiency virus-associated lymphoma: AIDS Malignancy Consortium study 020. Biol Blood Marrow Transplant. 2008 Jan;14(1):59-66. doi: 10.1016/j.bbmt.2007.03.014.