Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
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 doctors to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have recurrent or refractory Hodgkin's lymphoma or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: mesna Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2002 |
OBJECTIVES:
- Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation (PBSCT) in patients who achieve a complete remission or partial remission.
- Estimate the post complete/partial remission failure-free survival rate in these patients.
- Characterize the time to recovery of normal bone marrow function after transplantation in these patients.
OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given.
The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following:
- Carmustine IV over 3 hours on days -8, -7, and -6
- Etoposide continuous IV over days -8, -7, and -6
- Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2
- Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine.
PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma in first relapse or refractory after primary induction therapy
Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with more than one nodal region involved at relapse or refractory after primary induction therapy (i.e., failed to achieve remission at the conclusion of standard induction chemotherapy)
- No prior radiotherapy only for low stage nodal disease
- No greater than 4 courses of standard chemotherapy for low stage nodal disease
- CSF or bone marrow involvement at time of study entry is allowed
PATIENT CHARACTERISTICS:
Age:
- 1 to 21 (at initial diagnosis)
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- SGOT or SGPT less than 2.5 times normal
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL
- Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or 24 hour urine collection for creatinine clearance
Cardiovascular:
- Shortening fraction of at least 28% by echocardiogram
- Ejection fraction of at least 40% by radionuclide angiogram echocardiogram
Pulmonary:
- Total lung capacity (TLC) at least 50% OR
- Vital capacity (VC) at least 65% of normal
- DLCO at least 55% of normal
- For children who are uncooperative to pulmonary function testing, no dyspnea at rest or with mild exercise, and a pulse oximetry of at least 95%
Other:
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Contacts and Locations
Show 235 Study Locations| Study Chair: | Richard E. Harris, MD | Children's Hospital Medical Center, Cincinnati |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002941 History of Changes |
| Other Study ID Numbers: | CDR0000065390, COG-A5962, CCG-A5962, POG-A5962, CCG-5962 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood lymphoblastic lymphoma childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma |
recurrent/refractory childhood Hodgkin lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Cyclophosphamide Etoposide phosphate Etoposide |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 13, 2013