Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00006029
First received: July 5, 2000
Last updated: July 12, 2016
Last verified: July 2016
  Purpose

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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed or refractory Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: gemcitabine hydrochloride
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: vinorelbine tartrate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: July 2000
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vinorelbine + gemcitabine + doxorubicin - higher doses

Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome.

Patients are followed every 6 months for 2 years and then annually for 6 years.

Drug: gemcitabine hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride Drug: vinorelbine tartrate
Experimental: vinorelbine + gemcitabine + doxorubicin - lower doses

Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome.

Patients are followed every 6 months for 2 years and then annually for 6 years.

Drug: gemcitabine hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride Drug: vinorelbine tartrate

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and toxicity of gemcitabine, vinorelbine, and doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
  • Determine the complete and partial response rates of patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Phase I:

  • Patients receive vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and doxorubicin HCl liposome IV over 30-60 minutes on days 1 and 8. Treatment continues every 21 days for 2-6 courses in the absence of unacceptable toxicity or disease progression. Patients who respond to treatment after 2 or more courses may stop protocol therapy to undergo peripheral blood stem cell transplantation.

Cohorts of 3-6 patients receive escalating doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with gemcitabine, vinorelbine, and doxorubicin HCl liposome at the recommended phase II dose.

Phase II:

  • Patients are assigned to 1 of 2 treatment groups.

    • Group 1: Patients who have not undergone prior transplantation receive vinorelbine, gemcitabine, and doxorubicin HCl liposome as in phase I.
    • Group 2: Patients who have undergone prior transplantation receive lower doses of vinorelbine, gemcitabine, and doxorubicin HCl liposome as in group 1.

Patients are followed every 6 months for 2 years and then annually for 6 years.

PROJECTED ACCRUAL: Approximately 3-100 patients (3-42 for phase I and 20-58 for phase II [29 per group]) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy

    • Core biopsy is acceptable if adequate tissue is obtained for primary diagnosis and immunophenotyping
    • Bone marrow biopsy is not acceptable as sole means of diagnosis
  • Measurable disease

    • Tumor mass greater than 1 cm

PATIENT CHARACTERISTICS:

Age:

  • Any age

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL unless history of Gilbert's disease
  • AST no greater than 2 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • LVEF at least 45% by MUGA (for patients whose lifetime cumulative doxorubicin dose exceeds 400 mg/m^2)

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior gemcitabine, vinorelbine, or doxorubicin HCl liposome
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormones except for nondisease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure
  • No concurrent dexamethasone or other steroidal antiemetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006029

  Show 76 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Nancy L. Bartlett, MD Washington University Siteman Cancer Center
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00006029     History of Changes
Other Study ID Numbers: CALGB-59804  CLB-59804  CDR0000068042 
Study First Received: July 5, 2000
Last Updated: July 12, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Vinorelbine
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on December 08, 2016