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Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
This study is ongoing, but not recruiting participants.
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005613
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous 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 compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.


Condition Intervention Phase
Lymphoma
Drug: carmustine
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Drug: fludarabine phosphate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
Drug Information available for: Dexamethasone Cyclophosphamide Cytarabine hydrochloride Cisplatin Fludarabine Etoposide Dexamethasone acetate Mitoxantrone Mitoxantrone hydrochloride Fludarabine monophosphate Doxiproct plus Methylprednisolone Cytarabine Carmustine Dexamethasone Sodium Phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of these 2 regimens in these patients.

OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g., dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone (FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days

  • 6 to -4. PBSC are infused on day 0. Patients are followed weekly for 3 months, then monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that has relapsed or failed to achieve complete remission after first line induction chemotherapy Intermediate or high grade (including mantle cell, but excluding lymphoblastic disease) No more than 1 prior salvage chemotherapy regimen, e.g.: Dexamethasone, high dose cytarabine, and cisplatin (DHAP) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP) Low grade No more than 2 prior salvage chemotherapy regimens, e.g.: Fludarabine, mitoxantrone, and dexamethasone (FND) ESHAP DHAP OR Histologically proven stage III or IV Hodgkin's disease that has relapsed or failed to achieve remission after combination induction chemotherapy Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, liver/marrow involvement) No more than 2 prior salvage chemotherapy regimens Allogeneic stem cell transplantation group: Availability of 6 antigen (A, B, and DR loci) HLA matched sibling donor No active CNS disease 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: 15 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 3 times normal PT and PTT normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 45% by MUGA scan or echocardiogram No myocardial infarction within the past 6 months No arrhythmias unless medically controlled Pulmonary: FEV1 at least 50% predicted DLCO at least 50% predicted Other: No diabetes mellitus or thyroid disease unless medically controlled No active serious infection HIV negative Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005613

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Steven C. Goldstein, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067743, MCC-11306, MCC-IRB-4250, NCI-G00-1746
Study First Received: May 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005613     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Dexamethasone
Methylprednisolone
Hormone Antagonists
Lymphoma, Mantle-Cell
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Mantle Cell Lymphoma
Hormones
Follicular Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Etoposide
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Carmustine
Glucocorticoids
B-cell Lymphomas
Fludarabine
Mitoxantrone
Lymphoma, Non-Hodgkin
Antimetabolites
Immunologic Factors
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Prednisolone acetate
Cyclophosphamide
Neuroprotective Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Dexamethasone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Cyclophosphamide
Neuroprotective Agents
Hormones
Sensory System Agents
Therapeutic Uses
Analgesics
Lymphoma
Alkylating Agents
Cytarabine
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Carmustine
Gastrointestinal Agents
Methylprednisolone acetate

ClinicalTrials.gov processed this record on May 07, 2009