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Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma

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Trial Information

Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma


Background:

- Mantle cell lymphoma presents a particular clinical challenge because it is aggressive
and incurable with chemotherapy. Thus, novel treatment approaches are needed.

- In follicular center cell lymphomas, another incurable disease, recent evidence
suggests that molecular complete remissions may be achieved following idiotype
vaccination in patients who have achieved minimal residual disease with combination
chemotherapy.

- These results suggest that idiotype vaccines may be able to induce a clinically
significant immune response against lymphoma.

Objectives:

- To assess if EPOCH-R/idiotype vaccination is associated with a median progression-free
survival consistent with 36 months;

- To assess if rituximab affects generation of T-cell immunity against the idiotype.

- To compare T-cell immunity using two different methods of isolating the idiotype
protein.

Eligibility:

- Tissue diagnosis of mantle cell lymphoma.

- Age greater than or equal to 18 years.

- Previously untreated with cytotoxic chemotherapy. All stages of disease.

- Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater
than 000/microl of circulating tumor cells in the blood. ECOG performance status less
than or equal to 3.

Design:

- In the present study, we propose to investigate the efficacy of idiotype vaccine
treatment in previously untreated patients with mantle cell lymphomas. In order to
achieve minimal residual disease, patients will receive 6 cycles EPOCH chemotherapy and
rituximab (EPOCH-R) followed by 5 idiotype vaccine injections.

- This study has completed accrual of 26 patients and is only open for follow-up.

Inclusion Criteria


- INCLUSION CRITERIA:

Tissue diagnosis of mantle cell lymphoma (confirmed in Laboratory of Pathology). Blastic
cell variant will be eligible.

Age greater than or equal to 18.

Previously untreated with cytotoxic chemotherapy. Patients may have received local
radiation or a short course of steroids for control of symptoms.

All stages of disease.

Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than
1000/microliters of circulating tumor cells in the blood.

ECOG performance status of less than or equal to 3.

Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater
than 60 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients
with Gilbert's syndrome as defined by greater than 80% unconjugated; ANC greater than 1000
and platelets greater than 100,000) unless impairment due to organ involvement by
lymphoma.

No active symptomatic ischemic heart disease, myocardial infarction or congestive heart
failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.

Ability to give informed consent.

EXCLUSION CRITERIA:

Antibodies to HIV or presence of hepatitis B surface antigen.

Pregnant or lactating.

Prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively
treated in situ of the cervix.

Involvement of central nervous system by lymphoma.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

000133

NCT ID:

NCT00005780

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Mantle Cell Lymphoma
  • Monoclonal Antibody
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892