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

NCT00365274 | Terminated Phase 2 Results

• 4 other identifiers: NCI-2009-001622005-0627N01CM62202N01CM17003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Study Arms (1)

SGN-30 + Combination Chemotherapy

EXPERIMENTAL

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.

Drug: Cyclophosphamide; Drug: Doxorubicin hydrochloride; Drug: vincristine sulfate; Drug: prednisone; Drug: SGN-30

Interventions

Cyclophosphamide DRUG

Given IV 750 mg/m\^2 day 1

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

SGN-30 + Combination Chemotherapy

Doxorubicin hydrochloride DRUG

Given 50 mg/m\^2 IV day 1

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

SGN-30 + Combination Chemotherapy

vincristine sulfate DRUG

Given 1.4 mg/m\^2 IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS

SGN-30 + Combination Chemotherapy

prednisone DRUG

100 mg orally daily days 1 - 5

Also known as: DeCortin, Deltra

SGN-30 + Combination Chemotherapy

SGN-30 DRUG

12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.

Also known as: Monoclonal antibody SGN-30 monotherapy

SGN-30 + Combination Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas MD Anderson Cancer Center official website

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, T-Cell

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Michelle Fanale, MD / Associate Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Michelle Fanale, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 17, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 2, 2014
• Results First Posted: November 18, 2013

Record last verified: 2013-11

Locations

US (1)