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bleomycin sulfate

Stanford V regimen

doxorubicin hydrochloride

etoposide

mechlorethamine hydrochloride

prednisone

vinblastine sulfate

vincristine sulfate

radiation therapy

Sandra J. Horning, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkin's disease.

OBJECTIVES: I. Determine the progression-free and overall survival at 5 and 10 years after a short-term Stanford V regimen comprising mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field radiotherapy in patients with favorable, early-stage Hodgkin's disease. II. Determine whether the early and late toxic effects of treatment can be minimized by avoiding staging laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and volume of radiotherapy in these patients. III. Determine the freedom from second disease progression at 5 and 10 years after treatment and treatment-related toxicity in these patients. IV. Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and 29; doxorubicin IV and vinblastine IV on days 1, 15, 29, and 43; oral prednisone every other day on days 1-36 followed by tapered doses; vincristine IV and bleomycin IV on days 8, 22, 36, and 50; and etoposide IV on days 15, 16, 43, and 44. Beginning 2 weeks after completion of chemotherapy and when blood counts recover, patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks. Quality of life is assessed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease

A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

National Cancer Institute (NCI)

Stanford University

Symptoms and General Pathology

Sclerosis

Dacarbazine

ABVD regimen

dacarbazine

Peter J. Hoskin, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.

OBJECTIVES:

* Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
* Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.

All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.

Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease

Mount Vernon Cancer Centre at Mount Vernon Hospital

A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule

Bleomycin sulfate

Doxorubicin hydrochloride

Mechlorethamine hydrochloride

Vincristine sulfate

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.

OBJECTIVES:

* Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
* Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
* Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
* Determine the acute toxicity associated with this treatment.
* Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.

OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.

* Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
* Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease	NCT00002714	Lymphoma	bleomycin sulfa... Stanford V regi... doxorubicin hyd... etoposide mechlorethamine... prednisone vinblastine sul... vincristine sul... radiation thera...	16 Years - 60 Years	National Cancer Institute (NCI)
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease	NCT00002714	Lymphoma	bleomycin sulfa... Stanford V regi... doxorubicin hyd... etoposide mechlorethamine... prednisone vinblastine sul... vincristine sul... radiation thera...	16 Years - 60 Years	National Cancer Institute (NCI)
Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma	NCT00041210	Lymphoma	bleomycin sulfa... ABVD regimen Stanford V regi... dacarbazine doxorubicin hyd... etoposide mechlorethamine... prednisone vinblastine sul... vincristine sul... radiation thera...	18 Years - 60 Years	National Cancer Institute (NCI)
Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma	NCT00041210	Lymphoma	bleomycin sulfa... ABVD regimen Stanford V regi... dacarbazine doxorubicin hyd... etoposide mechlorethamine... prednisone vinblastine sul... vincristine sul... radiation thera...	18 Years - 60 Years	National Cancer Institute (NCI)
Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma	NCT00002715	Lymphoma	Bleomycin sulfa... Stanford V regi... Doxorubicin hyd... Etoposide Mechlorethamine... Prednisone Vinblastine Vincristine sul...	18 Years - 60 Years	Stanford University

Spots Global Cancer Trial Database for stanford v regimen