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SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
This study has been terminated.
( Slow accrual. )

First Received on August 16, 2006.   Last Updated on July 28, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00365274
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Lymphoma
Biological: Monoclonal antibody SGN-30
Drug: Cyclophosphamide
Drug: Doxorubicin hydrochloride
Drug: Prednisone
Drug: Vincristine sulfate
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response rate of SGN-30 + CHOP combined therapy [ Time Frame: Every 3 cycles (21 day cycle) for evaluation of response ] [ Designated as safety issue: No ]
    Objective response rate (ORR) defined as the proportion of patients experiencing a complete or partial response to a regimen of SGN-30 + CHOP.


Secondary Outcome Measures:
  • Toxicity of monotherapy and combined therapy [ Time Frame: Every 3 cycles (21 day cycle) ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: August 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-30 + Combination Chemotherapy
SGN-30 3 weekly intravenous (IV) doses of 12 mg/kg; Cyclophosphamide IV 750 mg/m^2, Doxorubicin IV 50 mg/m^2 and Vincristine 1.4 mg/m^2 IV Day 1 of 3 week cycle; 100 mg/day orally for 5 days.
Biological: Monoclonal antibody SGN-30
3 weekly intravenous doses of 12 mg/kg
Drug: Cyclophosphamide
750 mg/m^2 Day 1 by vein over about 4 hours, once every 3 weeks
Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin hydrochloride
50 mg/m^2 day 1 (can be given either as bolus or as continuous infusion) by vein over about 4 hours, once every 3 weeks
Other Names:
  • Adriamycin
  • Adriamycin PFS
  • Adriamycin RDF
Drug: Prednisone
100 mg tablet by mouth once a day for 5 days starting Day 1
Drug: Vincristine sulfate
1.4 mg/m^2 (maximum 2 mg) day 1 by vein over about 4 hours, once every 3 weeks

Detailed Description:

OBJECTIVES:

Primary

  • 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).
  • Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.

Secondary

  • Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
  • Determine the response duration in patients treated with this regimen.
  • Correlate response with pretreatment serum CD30 levels.
  • 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.

PROJECTED ACCRUAL: A total of 54 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

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed newly diagnosed systemic anaplastic large cell lymphoma. Tissue should be available for the determination of ALK status prior to study entry (t2;5, ALK-NPM translocation).
  2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
  3. 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.
  4. Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of SGN-30 in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric phase 2 combination trials.
  5. Eastern Cooperative Oncology Group (ECOG) performance status </= 1 (Karnofsky >/= 70%).
  6. Patients must have normal organ and marrow function as defined below: leukocytes >/= 3,000/mcL; Absolute neutrophile count >/= 1,500/mcL; platelets >/= 100,000/mcL unless due to lymphoma (i.e. splenomegaly and/or bone marrow involvement); total bilirubin </= 1.5 times Upper limit of normal; AST(SGOT)/ALT(SGPT) </= 2.5 x institutional upper limit of normal; creatinine </=1.5 times upper limit of normal unless due to lymphoma OR creatinine clearance >/= 60 mL/min for patients with creatinine levels above institutional normal.
  7. Cardiac ejection fraction of 50% or higher.
  8. The effects of SGN-30 and CHOP on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Prior chemotherapy for ALCL.
  2. Patients may not be receiving any other investigational agents.
  3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis. Patients with brain metastases often develop progressive neurologic dysfunction that may confound the evaluation of neurologic toxicities and other adverse events.
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to SGN-30.
  5. Patients with rapidly progressing disease or bulky disease defined as a mass of > 7 cm in largest diameter.
  6. Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. Pregnant women are excluded from this study because SGN-30 is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with SGN-30, breastfeeding should be discontinued if the mother is treated with SGN-30. These potential risks may also apply to other agents used in this study.
  8. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SGN-30. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  9. Concurrent or previous malignancy with <90% probability of survival at 5 years.
  10. Patients with primary cutaneous ALCL (only skin involvement).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365274

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michelle Fanale, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michelle A. Fanale, MD / Assistant Professor, M. D. Anderson Cancer Center at University of Texas
ClinicalTrials.gov Identifier: NCT00365274     History of Changes
Other Study ID Numbers: MDA-2005-0627, P30CA016672, MDA-2005-0627, NCI-7372, CDR0000492803
Study First Received: August 16, 2006
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
anaplastic large cell lymphoma

Additional relevant MeSH terms:
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
Cyclophosphamide
Doxorubicin
Prednisone
Vincristine
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

ClinicalTrials.gov processed this record on February 09, 2012