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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00017290
Other study ID # CDR0000068673
Secondary ID GENITOPE-G2000-0
Status Active, not recruiting
Phase Phase 3
First received June 6, 2001
Last updated December 3, 2013
Start date November 2000

Study information

Verified date August 2002
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.


Description:

OBJECTIVES:

- Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF).

- Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response.

- Compare the safety and toxic effects of these immunotherapy regimens in this patient population.

- Compare the time to treatment failure and survival of patients treated with these regimens.

- Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses.

At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.

- Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.

Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months.

Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years.

PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma

- At least 1 bidimensionally measurable lesion by radiography, in addition to lesion removed for biopsy

- No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

Renal:

- Creatinine less than 1.5 times ULN

Other:

- No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

- No history of autoimmune disease

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior antibody therapy for lymphoma

Chemotherapy:

- No prior cytotoxic therapy for lymphoma

Endocrine therapy:

- No prior corticosteroids for lymphoma

- At least 12 months since prior corticosteroids or immunosuppressants for other conditions

- Prior transient corticosteroids (prior to CT imaging) or optical solutions allowed

Radiotherapy:

- Prior radiotherapy for lymphoma (no more than 2 sites of limited disease) allowed

Surgery:

- See Disease Characteristics

Other:

- No concurrent participation in other therapeutic clinical trial

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
autologous immunoglobulin idiotype-KLH conjugate vaccine

keyhole limpet hemocyanin

sargramostim

Drug:
cyclophosphamide

prednisone

vincristine sulfate


Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
Canada British Columbia Cancer Agency Vancouver British Columbia
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Mountain States Tumor Institute - Boise Boise Idaho
United States Rush Cancer Institute at Rush University Medical Center Chicago Illinois
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Rocky Mountain Cancer Centers - Midtown Denver Colorado
United States SuperGen, Incorporated Dublin California
United States Shands Cancer Center at the University of Florida Health Science Center Gainesville Florida
United States California Cancer Care, Inc. Greenbrae California
United States Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Indiana University Cancer Center Indianapolis Indiana
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States Sarah Cannon Cancer Center at Centennial Medical Center Nashville Tennessee
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska
United States Cancer Institute at Oregon Health and Science University Portland Oregon
United States Washington University School of Medicine Saint Louis Missouri
United States Stanford Cancer Center at Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Genitope Corporation

Countries where clinical trial is conducted

United States,  Canada, 

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