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Combination Chemotherapy and Monoclonal Antibody Therapy Followed by Vaccine Therapy in Treating Patients With Mantle Cell Lymphoma
This study has been completed.
First Received: March 2, 2007   No Changes Posted
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020215
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy, monoclonal antibody therapy, and vaccine therapy may be an effective treatment for mantle cell lymphoma.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and monoclonal antibody therapy plus vaccine therapy in treating patients who have mantle cell lymphoma that has not been previously treated with chemotherapy.


Condition Intervention Phase
Noncontiguous Stage II Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Stage I Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Drug: autologous tumor cell vaccine
Drug: cyclophosphamide
Drug: doxorubicin
Drug: etoposide
Drug: filgrastim
Drug: keyhole limpet hemocyanin
Drug: prednisone
Drug: rituximab
Drug: sargramostim
Drug: vincristine
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R) Followed By Immunotherapy With Autologous Tumor-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


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

Study Start Date: June 2000
Detailed Description:

OBJECTIVES: I. Determine whether etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) followed by immunotherapy with autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin plus sargramostim (GM-CSF) is associated with 36-month median progression-free survival in patients with previously untreated mantle cell lymphoma.

II. Assess whether idiotype vaccine generates tumor-specific T-cell response in this patient population.

III. Determine the response rate in these patients receiving this treatment. IV. Determine the toxicity of EPOCH-R in these patients.

PROTOCOL OUTLINE: Patients receive rituximab IV on day 1 immediately followed by doxorubicin, etoposide, and vincristine IV over 96 hours on days 1-4, oral prednisone twice daily on days 1-5, and cyclophosphamide IV over 15 minutes on day 5. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 6 and continuing until blood counts recover. Treatment repeats every 3 weeks for 6 courses in the absence of unacceptable toxicity. Patients with stable disease or a complete response receive 2 additional courses of therapy with a maximum of 6 courses.

Beginning at least 12 weeks after completion of chemotherapy and rituximab, patients receive vaccination with autologous tumor-derived immunoglobulin idiotype-keyhole limpet hemocyanin conjugate SC on day 1 and sargramostim (GM-CSF) SC on days 0-3 at weeks 12, 16, 20, 24, and 32 for a total of 5 courses.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL:

A total of 26 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed mantle cell lymphoma Blastic cell variant allowed All stages of disease Chemotherapy naive Lymph node at least 2 cm accessible for biopsy/harvest OR Greater than 1,000/mm3 of circulating tumor cells in the blood No CNS involvement by lymphoma --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Prior short course of steroids for symptom control allowed Radiotherapy: Prior local radiotherapy for symptom control allowed Surgery: Not specified --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Unless due to lymphoma: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL (5 mg/dL for Gilbert's syndrome as defined by more than 80% unconjugated) Hepatitis B surface antigen negative Renal: Unless due to lymphoma: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No active symptomatic ischemic heart disease No myocardial infarction or congestive heart failure within the past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior malignancy within the past 5 years except basal or squamous cell skin cancer or curatively treated carcinoma in situ of the cervix

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020215

Locations
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Wyndham Hopkins Wilson National Cancer Institute (NCI)
  More Information

No publications provided

Study ID Numbers: CDR0000068086, NCI-00-C-0133, NCI-1033
Study First Received: March 2, 2007
Last Updated: March 2, 2007
ClinicalTrials.gov Identifier: NCT00020215     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult low grade non-Hodgkin's lymphoma
adult non-Hodgkin's lymphoma
aggressive, adult non-Hodgkin's lymphoma
aggressive, contiguous stage II adult non-Hodgkin's lymphoma
aggressive, noncontiguous stage II adult non-Hodgkin's lymphoma
aggressive, noncontiguous stage II, stage III, and stage IV
aggressive, stage I adult non-Hodgkin's lymphoma
aggressive, stage I and contiguous stage II adult non-Hodgkin's lymphoma
aggressive, stage III adult non-Hodgkin's lymphoma
aggressive, stage IV adult non-Hodgkin's lymphoma
body system/site cancer
cancer
cellular diagnosis, adult non-Hodgkin's lymphoma
contiguous stage II adult non-Hodgkin's lymphoma
contiguous stage II mantle cell lymphoma
grade, adult non-Hodgkin's lymphoma
hematopoietic/lymphoid cancer
indolent or aggressive adult non-Hodgkin's lymphoma
lymphoma
mantle cell lymphoma
non-Hodgkin's lymphoma
noncontiguous stage II adult non-Hodgkin's lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II, stage III, and stage IV adult non-Hodgkin's lymphoma
stage I adult non-Hodgkin's lymphoma
stage I mantle cell lymphoma
stage II adult non-Hodgkin's lymphoma
stage II mantle cell lymphoma
stage III adult non-Hodgkin's lymphoma
stage III mantle cell lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Etoposide phosphate
Keyhole-limpet hemocyanin
Therapeutic Uses
Lymphoma
Etoposide
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Adjuvants, Immunologic
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009