Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

Phase 3 Unknown Genitope Corporation

RandomizedDouble-blindTreatment

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.

Timeline

Start: 2000-11
Primary completion: —
Completion: —

Outcome

Missed primary endpoint

paper no significant difference was observed in either PFS or time to next therapy between the two arms. PMID 24799467 ↗

Publications

Levy R, Ganjoo KN, Leonard JP, Vose JM, Flinn IW, Ambinder RF, Connors JM, Berinstein NL, Belch AR, Bartlett NL, Nichols C, Emmanouilides CE, Timmerman JM, Gregory SA, Link BK, Inwards DJ, Freedman AS, Matous JV, Robertson MJ, Kunkel LA, Ingolia DE, Gentles AJ, Liu CL, Tibshirani R, Alizadeh AA, Denney DW Jr. Active idiotypic vaccination versus control immunotherapy for follicular lymphoma. J Clin Oncol. 2014 Jun 10;32(17):1797-803. doi: 10.1200/JCO.2012.43.9273. Epub 2014 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MyVax	Vaccine	—	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Prednisone	Other / unclassified	—	Oral
Background	Vincristine	Small molecule	—	Intravenous
Background	keyhole limpet hemocyanin	Vaccine	—	Subcutaneous
Background	sargramostim	Protein / enzyme biologic	—	Subcutaneous