Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Stage III or Stage IV Non-Hodgkin's Lymphoma

NCT00004198 | Completed Phase 2 FDA Drug

• 3 other identifiers: 0196-99-FBP30CA036727GENITOPE-9901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma

Interventions

keyhole limpet hemocyanin BIOLOGICAL

sargramostim BIOLOGICAL

tumor cell-based vaccine therapy BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed stage III or IV, indolent non-Hodgkin's lymphoma
• Follicular small cleaved cell
• Follicular mixed small cleaved and large cell with less than 50% large cells
• Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy
• Must have adequate circulating lymphoma cells
• Over 18 years old
• Karnofsky 80-100%
• WBC greater than 2,500/mm3
• Platelet count greater than 100,000/mm3
• Hemoglobin at least 10 g/dL
• Bilirubin less than 2 mg/dL
• SGOT/SGPT less than 2 times normal
• Creatinine less than 2 mg/dL
• HIV negative
• At least 2 months since prior non-physiologic doses of prednisone of greater than 20 mg or equivalent

You may not qualify if:

• No intermediate, high grade, or other non-Hodgkin's lymphomas (e.g., mantle cell, monocytoid B cell, marginal zone, small lymphocytic, chronic lymphocytic leukemia, or follicular large cell)
• No CNS metastasis
• No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study
• No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• No prior biologic therapy for lymphoma
• No prior cytotoxic therapy for lymphoma
• No prior steroids for lymphoma
• No concurrent maintenance steroids or greater than 5 mg of daily prednisone or equivalent
• No prior radiotherapy for lymphoma 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator
• Genitope Corporation: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

keyhole-limpet hemocyanin; sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• Julie M. Vose, MD

  University of Nebraska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: May 21, 2004
• Study Start: June 25, 1999
• Primary Completion: January 1, 2002
• Study Completion: November 20, 2003
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

US (1)