SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00337194

Purpose

RATIONALE: Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, vinorelbine, and doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving SGN-30 together with combination chemotherapy may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving SGN-30 together with combination chemotherapy works in treating patients with relapsed or refractory Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: monoclonal antibody SGN-30 Drug: gemcitabine hydrochloride Drug: pegylated liposomal doxorubicin hydrochloride Drug: vinorelbine ditartrate Other: placebo	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Vinorelbine Gemcitabine Myocet Gemcitabine hydrochloride Vinorelbine tartrate Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Double-Blind, Placebo Control, Randomized, Treatment
Official Title:	A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636, IND #100057), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall response rate [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	141
Study Start Date:	April 2006
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.	Biological: monoclonal antibody SGN-30 given IV Drug: gemcitabine hydrochloride given IV Drug: pegylated liposomal doxorubicin hydrochloride given IV Drug: vinorelbine ditartrate given IV
Arm II (closed to accrual as of 12/4/07): Active Comparator Patients receive placebo IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.	Drug: gemcitabine hydrochloride given IV Drug: pegylated liposomal doxorubicin hydrochloride given IV Drug: vinorelbine ditartrate given IV Other: placebo given IV

Detailed Description:

OBJECTIVES:

Determine the complete and partial response rates after treatment with monoclonal antibody SGN-30, gemcitabine, vinorelbine, and pegylated doxorubicin HCl liposome in patients with relapsed or refractory Hodgkin's lymphoma.
Assess the time to progression and overall survival of patients treated with this regimen.
Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior stem cell transplantation (yes vs no).

Part 1: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity. Subsequent patients receive treatment on part 2.
Part 2: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive monoclonal antibody SGN-30 IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.
- Arm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours, vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90 minutes on days 1 and 8.

Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 141 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed CD30+ classical Hodgkin's lymphoma, including the following subtypes:
- Nodular sclerosis
- Lymphocyte-depleted
- Lymphocyte-rich
- Mixed cellularity
Original diagnostic specimen or specimen from relapse required
- Core needle biopsy allowed provided there is adequate tissue for primary diagnosis and immunophenotyping
- Bone marrow biopsy allowed provided nodal biopsy is available
- No fine needle aspirates
Relapsed or refractory disease after ≥ 1 prior therapy
Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm
- Nonmeasurable or evaluable disease allowed provided measurable disease is present
  - Nonmeasurable disease includes any of the following:
    - Bone lesions
    - Bone marrow involvement
    - Ascites
    - Pleural/pericardial effusion
    - Lymphangitis cutis/pulmonis
No nodular lymphocyte-predominant Hodgkin's lymphoma

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,200/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.0 mg/dL (in the absence of Gilbert's disease)
AST ≤ 2.0 times upper limit of normal
LVEF ≥ 45% by MUGA or ECHO
DLCO ≥ 50%
Not pregnant
Negative pregnancy test
No nursing during and for 6 months after completion of study treatment
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
No uncontrolled angina
No myocardial infarction within the past 6 months
No New York Heart Association class II-IV congestive heart failure

PRIOR CONCURRENT THERAPY:

At least 3 weeks since prior chemotherapy or radiotherapy and recovered
Prior autologous, allogeneic, or unrelated stem cell transplantation allowed
No prior anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated doxorubicin HCl liposome
No other concurrent chemotherapy
No concurrent steroids or hormones
- Steroids given for adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
No concurrent dexamethasone, except as needed to treat monoclonal antibody SGN-30 or pegylated doxorubicin HCl liposome infusion reactions, or as an anti-emetic on the day of chemotherapy
No concurrent palliative radiotherapy
No concurrent pegfilgrastim

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337194

Show 47 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Investigator:	Nancy L. Bartlett, MD	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Study Chair:	Kristie A. Blum, MD	Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Blum KA, Johnson JL, Jung SH, et al.: Serious pulmonary toxicity with SGN-30 and gemcitabine, vinorelbine, and liposomal doxorubicin in patients with relapsed/refractory Hodgkin lymphoma (HL): Cancer and Leukemia Group B (CALGB) 50502. [Abstract] Blood 112 (11): A-232, 2008.

Study ID Numbers:	CDR0000481448, CALGB-50502
Study First Received:	June 13, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00337194 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adult lymphocyte depletion Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:

Antimetabolites
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Vinblastine
Sclerosis
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Recurrence
Doxorubicin
Antibodies, Monoclonal

Anti-Bacterial Agents
Lymphatic Diseases
Antibodies
Vinorelbine
Radiation-Sensitizing Agents
Tubulin Modulators
Lymphoproliferative Disorders
Gemcitabine
Antineoplastic Agents, Phytogenic
Lymphoma
Hodgkin Disease
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Antibiotics, Antineoplastic
Antibodies, Monoclonal
Therapeutic Uses
Gemcitabine
Lymphoma
Hodgkin Disease
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Antibodies
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on March 16, 2009