A phase II study of thalidomide and vinblastine for palliative patients with Hodgkin's lymphoma.
BACKGROUND
Patients with Hodgkin's Lymphoma (HL) who relapse or progress after primary therapy and subsequent high dose chemotherapy with autologous stem cell transplantation (ASCT) cannot be cured with conventional treatment. We combined thalidomide (THAL), an agent with anti-angiogenic and immunomodulatory properties, with vinblastine, which is active after ASCT, to determine the objective response rate, improvement in B symptoms and toxicity in patients with refractory HD.


METHODS
Patients were eligible if they HD that progressed after chemotherapy and ASCT or had declined or were ineligible for curative therapy. Treatment consisted of THAL 200 mg orally given daily. After 2 weeks, VBL 6 mg IV was given weekly x 6 doses on an eight-week cycle. Response and toxicity assessment occurred following each cycle.


RESULTS
Eleven patients were enrolled, 1 progressed within 6 days of study enrollment and was subsequently treated with alternative palliative therapy and thus 11 patients are response evaluable and 10 are evaluable for toxicity.


METHODS
relapsed after ASCT: 7; median number of prior chemotherapy regimens: 3 (range 1-5); median time to progression post-ASCT: 7 months (range 2-29). Four patients had a partial response to treatment (response rate 36%); two patients had stable disease. B symptoms were present at enrollment in four patients and resolved completely on treatment in two patients. Five had disease progression within 3 months of starting treatment. The median duration of response was 9 months (range 0-22 months). Toxicity was mild and limited to grade 2 neuropathy in 6 patients and grade 2 or 3 neutropenia in 4 patients.


CONCLUSIONS
In this small study in chemotherapy- refractory HL, THAL and VBL demonstrated encouraging activity with some durable responses and acceptable toxicity. These results suggest that chronic low dose chemotherapy combined with less toxic immunomodulatory or anti-angiogenic drugs warrants further study.
Kuruvilla
John
J
The University of Toronto Autologous Blood and Marrow Transplant Program, Princess Margaret Hospital, Toronto, Ont., Canada. john.kuruvilla@uhn.on.ca
Song
Kevin
K
Mollee
Peter
P
Panzarella
Tony
T
McCrae
Jan
J
Nagy
Tracy
T
Crump
Michael
M
Keating
Armand
A
D000284:Administration, Oral; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006689:Hodgkin Disease / Q000150:complications / Q000628:therapy*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods; D012074:Remission Induction; D033581:Stem Cell Transplantation / Q000009:adverse effects; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects
D013792:Thalidomide; D014747:Vinblastine