SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT00337194 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02822CALGB-50502U10CA031946P30CA014236
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.

Conditions

Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Recurrent Adult Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response (OR)

  The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \>= 50% reduction in sum of the product of diameters of indicator lesions.

  Up to 10 years

Secondary Outcomes (2)

• Event Free Survival (EFS)

  Up to 10 years

• Overall Survival (OS) At 1 Year

  1 year

Other Outcomes (3)

• Peak Serum Level of Monoclonal Antibody SGN-30

  Up to day 21 of course 6

• sCD30 Levels

  Up to day 21 of course 6

• Fc Gamma Receptor Polymorphisms

  Baseline

Study Arms (2)

Arm I (SGN-30, chemotherapy)

EXPERIMENTAL

Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.

Biological: monoclonal antibody SGN-30; Drug: vinorelbine tartrate; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

Arm II (placebo, chemotherapy)

ACTIVE COMPARATOR

Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8.

Other: placebo; Drug: vinorelbine tartrate; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

monoclonal antibody SGN-30 BIOLOGICAL

Given IV

Also known as: SGN-30

Arm I (SGN-30, chemotherapy)

placebo OTHER

Given IV

Also known as: PLCB

Arm II (placebo, chemotherapy)

vinorelbine tartrate DRUG

Given IV

Also known as: Eunades, navelbine ditartrate, NVB, VNB

Arm I (SGN-30, chemotherapy); Arm II (placebo, chemotherapy)

pegylated liposomal doxorubicin hydrochloride DRUG

Given IV

Also known as: CAELYX, Dox-SL, DOXIL, doxorubicin hydrochloride liposome, LipoDox

Arm I (SGN-30, chemotherapy); Arm II (placebo, chemotherapy)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Arm I (SGN-30, chemotherapy); Arm II (placebo, chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (SGN-30, chemotherapy); Arm II (placebo, chemotherapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (SGN-30, chemotherapy); Arm II (placebo, chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy
• Note: Patients with nodular lymphocyte predominant HL are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and mixed cellularity HL may be enrolled
• Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable; if the original diagnostic specimen is not available, specimens obtained at relapse may be submitted; if multiple specimens are available, please submit the most recent; failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
• Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =\< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study
• Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated liposomal doxorubicin is not permitted
• No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
• Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be \>= 45%
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Measurable disease must be present on either physical examination or imaging studies; evaluable or non-measurable disease alone is not acceptable
• Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm
• Non-measurable disease includes all other lesions, including small lesions (\< 10 mm) and truly non-measurable lesions
• Lesions that are considered non-measurable include the following:
• Bone lesions (lesions, if present, should be noted)
• Bone marrow involvement (if present, this should be noted)
• Ascites

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

SGN-30 monoclonal antibody; Brentuximab Vedotin; Vinorelbine; liposomal doxorubicin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Kristie Blum
• Organization: The Ohio State University

kristie.blum@osumc.edu

Study Officials

• Kristie Blum

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2014
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2014-10

Locations

US (1)