search
Back to results

SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

Primary Purpose

Anaplastic Large Cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Doxorubicin hydrochloride
vincristine sulfate
prednisone
SGN-30
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Large Cell Lymphoma focused on measuring non-Hodgkin's lymphoma, NHL, murine monoclonal antibody, mAb, SGN-30, CHOP, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, Prednisone, anaplastic large cell lymphoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, B-Cell, Lymphoma, T-Cell, Antibodies, Antibodies, Monoclonal, Immunologic Factors, Physiological Effects of Drugs, Pharmacologic Actions, Immunosuppressive Agents, Antirheumatic Agents, Therapeutic Uses, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Antibiotics, Antineoplastic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL) Tissue available for the determination of anaplastic large cell kinase (ALK) status [t(2;5), ALK-NPM translocation] prior to study entry Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100% White Blood Count (WBC) >= 3,000/mm³ Absolute neutrophil count >= 1,500/mm³ Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone marrow involvement]) Bilirubin =< 1.5 times upper limit of normal (ULN) AST or ALT =< 2.5 times ULN Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60 mL/min Left ventricular ejection fraction (LVEF) >= 50% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion Criteria: No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in largest diameter No primary cutaneous ALCL No known brain metastases No concurrent combination antiretroviral therapy for HIV-positive patients No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30 No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situations that would preclude study compliance No prior or other concurrent malignancy with < 90% probability of survival at 5 years No other concurrent anticancer agents or therapies No prior chemotherapy for ALCL No other concurrent investigational agents

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGN-30 + Combination Chemotherapy

Arm Description

Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously(IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2006
Last Updated
May 29, 2014
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00365274
Brief Title
SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
Official Title
A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial is studying how well giving SGN-30 together with combination chemotherapy works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy 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
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of monoclonal antibody SGN-30 in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients with newly diagnosed anaplastic large cell lymphoma (ALCL). II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy. SECONDARY OBJECTIVES: I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo. II. Determine the response duration in patients treated with this regimen. III. Correlate response with pretreatment serum CD30 levels. IV. Determine response to single-agent monoclonal antibody SGN-30. OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large cell kinase (ALK) status (positive vs negative). Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over 2 hours once weekly for 3 weeks. Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for at least 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Large Cell Lymphoma
Keywords
non-Hodgkin's lymphoma, NHL, murine monoclonal antibody, mAb, SGN-30, CHOP, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, Prednisone, anaplastic large cell lymphoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, B-Cell, Lymphoma, T-Cell, Antibodies, Antibodies, Monoclonal, Immunologic Factors, Physiological Effects of Drugs, Pharmacologic Actions, Immunosuppressive Agents, Antirheumatic Agents, Therapeutic Uses, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Antibiotics, Antineoplastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGN-30 + Combination Chemotherapy
Arm Type
Experimental
Arm Description
Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously(IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
CPM, CTX, Cytoxan, Endoxan, Endoxana
Intervention Description
Given IV 750 mg/m^2 day 1
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Other Intervention Name(s)
ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Intervention Description
Given 50 mg/m^2 IV day 1
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
leurocristine sulfate, VCR, Vincasar PFS
Intervention Description
Given 1.4 mg/m^2 IV
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
DeCortin, Deltra
Intervention Description
100 mg orally daily days 1 - 5
Intervention Type
Drug
Intervention Name(s)
SGN-30
Other Intervention Name(s)
Monoclonal antibody SGN-30 monotherapy
Intervention Description
12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL) Tissue available for the determination of anaplastic large cell kinase (ALK) status [t(2;5), ALK-NPM translocation] prior to study entry Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100% White Blood Count (WBC) >= 3,000/mm³ Absolute neutrophil count >= 1,500/mm³ Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone marrow involvement]) Bilirubin =< 1.5 times upper limit of normal (ULN) AST or ALT =< 2.5 times ULN Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60 mL/min Left ventricular ejection fraction (LVEF) >= 50% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion Criteria: No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in largest diameter No primary cutaneous ALCL No known brain metastases No concurrent combination antiretroviral therapy for HIV-positive patients No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30 No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situations that would preclude study compliance No prior or other concurrent malignancy with < 90% probability of survival at 5 years No other concurrent anticancer agents or therapies No prior chemotherapy for ALCL No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Fanale, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
The University of Texas MD Anderson Cancer Center official website

Learn more about this trial

SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

We'll reach out to this number within 24 hrs