Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

NCT00002715 | Completed Phase 2

• 5 other identifiers: IRB-13467SUMC-G2/G3CDR0000064551SQL 76234NCI-H96-0806
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma

Keywords

Stage I adult Hodgkin lymphoma; Stage II adult Hodgkin lymphoma; Stage III adult Hodgkin lymphoma; Stage IV adult Hodgkin lymphoma; Adult lymphocyte predominant Hodgkin lymphoma; Adult lymphocyte depletion Hodgkin lymphoma; Adult nodular sclerosis Hodgkin lymphoma; Adult mixed cellularity Hodgkin lymphoma

Study Arms (1)

Combination Chemotherapy (Stanford V)

EXPERIMENTAL

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

Biological: Bleomycin sulfate; Drug: Stanford V regimen; Drug: Doxorubicin hydrochloride; Drug: Etoposide; Drug: Mechlorethamine hydrochloride; Drug: Prednisone; Drug: Vinblastine; Drug: Vincristine sulfate

Interventions

Bleomycin sulfate BIOLOGICAL

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Stanford V regimen DRUG

Combination Chemotherapy (Stanford V)

Doxorubicin hydrochloride DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Etoposide DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Mechlorethamine hydrochloride DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Prednisone DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Vinblastine DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Vincristine sulfate DRUG

A component of the Stanford V regimen.

Combination Chemotherapy (Stanford V)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma of any histology * Unfavorable disease required * Clinical stage IIIA, IIIB, IV, or IIB (non-bulky) * Locally extensive stage I or II with either of the following: * Mediastinal mass greater than 1/3 the maximum intrathoracic diameter * Two or more extranodal sites PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior malignancy except nonmelanomatous skin cancer * No significant concurrent illness that precludes protocol participation PRIOR CONCURRENT THERAPY: * No prior treatment for Hodgkin's lymphoma Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (2)

• Horning SJ, Rosenberg SA, Hoppe RT. Brief chemotherapy (Stanford V) and adjuvant radiotherapy for bulky or advanced Hodgkin's disease: an update. Ann Oncol. 1996;7 Suppl 4:105-8. doi: 10.1093/annonc/7.suppl_4.s105.

  PMID: 8836420 RESULT

• Bartlett NL, Rosenberg SA, Hoppe RT, Hancock SL, Horning SJ. Brief chemotherapy, Stanford V, and adjuvant radiotherapy for bulky or advanced-stage Hodgkin's disease: a preliminary report. J Clin Oncol. 1995 May;13(5):1080-8. doi: 10.1200/JCO.1995.13.5.1080.

  PMID: 7537796 RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Doxorubicin; Etoposide; Mechlorethamine; Prednisone; Vinblastine; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Sandra J. Horning, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1989
• Primary Completion: January 1, 2007
• Study Completion: October 1, 2015
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (1)