GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Status:

SUSPENDED

GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

Lead Sponsor:

Favrille

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by ...

Detailed Description

OBJECTIVES: Primary * Compare the 3-year disease-free survival of patients with high-intermediate- or high-risk bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with sargramos...

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
Bulky stage II or stage III or IV disease
Treatment naïve
International Prognostic Index score of 3 (high-intermediate) or 4/5 (high)
Lymphoma accessible for sampling or existing biopsy material judged suitable for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®)
No history of CNS lymphoma or meningeal lymphomatosis
No history of indolent lymphoma
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Platelet count \> 75,000/mm\^3
ALT and AST \< 2 times upper limit of normal
Not pregnant or nursing
No history of unresolved hepatitis B viral infection
No history of a treated prior malignancy unless in remission ≥ 2 years, except for treated nonmelanoma carcinomas of the skin or in situ cervical carcinomas or prostatic carcinomas
No contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on ECG)
No contraindication to vincristine (e.g., peripheral neuropathy)
No know HIV positivity
No serious nonmalignant disease, including any of the following:
Psychiatric disorders
Compromised pulmonary function
Congestive heart failure
Active bacterial, viral, or fungal infections
PRIOR CONCURRENT THERAPY:
No prior keyhole limpet hemocyanin
No planned radiotherapy during or after study therapy
No concurrent systemic immunosuppressive therapy (e.g., steroids)

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

480 Patients enrolled

Trial Details

Trial ID

NCT00324831

Last Update

December 18 2013

Active Locations (2)

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Page 1 of 1 (2 locations)

Tower Cancer Research Foundation

Beverly Hills, California, United States, 90211