Status:
TERMINATED
Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan may increase the ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of beta-glucan when given in combination with rituximab in pediatric patients with relapsed or progressive CD20-positive lymphoma or leukem...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- B-cell non-Hodgkin's lymphoma (NHL)
- Hodgkin's lymphoma
- Post-transplant lymphoproliferative disorder (PTLD)
- Lymphoblastic leukemia
- CD20-positive disease verified by immunophenotyping at original diagnosis, disease relapse, or disease progression
- Refractory to conventional therapy, defined as 1 of the following:
- Medically refractory HIV-associated NHL
- Refractory or recurrent lymphoblastic leukemia
- PTLD
- In \> first relapse or progression of B-cell NHL or Hodgkin's lymphoma
- Measurable (CT scan or MRI) or evaluable (marrow metastases or circulating lymphoblasts) disease within 4 weeks after completion of prior systemic (including systemic steroids) therapy
- PATIENT CHARACTERISTICS:
- Age
- Under 22
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 500/mm\^3\*
- Platelet count \> 10,000/mm\^3\* NOTE: \*Excluding patients with PTLD or CD20-positive lymphoblastic leukemia
- Hepatic
- Hepatic toxicity ≤ grade 2
- Renal
- Creatinine clearance ≥ 60 mL/min
- Renal toxicity ≤ grade 2
- Cardiovascular
- Cardiac toxicity ≤ grade 2
- Pulmonary
- Pulmonary toxicity ≤ grade 2
- Immunologic
- Human anti-mouse antibody (HAMA) ≤ 1,000 units/mL
- Human anti-chimeric antibody titer negative
- No active, life-threatening infections except Epstein-Barr virus-associated lymphoproliferative disorder
- No history of allergy to mouse proteins
- No history of allergy to rituximab or other chimeric monoclonal antibodies
- No history of allergy to beta-glucan or oats, barley, mushrooms, or yeast
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Grade 3 hearing deficit allowed
- Gastrointestinal toxicity ≤ grade 2
- Neurologic toxicity ≤ grade 2
- No severe major organ toxicity
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior rituximab
- No prior mouse antibodies
- No prior chimeric antibodies
- Chemotherapy
- Not specified
- Endocrine therapy
- See Disease Characteristics
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00087009
Start Date
May 1 2004
End Date
August 1 2008
Last Update
March 19 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021