INNO-206 in Patients With Small Cell Lung Cancer (SCLC)

NCT00472771 | Withdrawn Phase 2

• 1 other identifier: INNO-206-P2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.

Conditions

Small Cell Lung Cancer

Keywords

Recurrent extensive small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).

Secondary Outcomes (6)

• To determine the rates of stable disease and progressive disease.

• To determine time to progression.

• To determine progression-free survival.

• To determine overall survival.

• To evaluate the treatment-related toxicities in this patient population.

Interventions

INNO-206 DRUG

Eligibility Criteria

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

You may qualify if:

• Be ≥18 years old.
• Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at the time of enrollment into the study.
• Have responded to first-line platinum-based chemotherapy, but progressed or relapsed ≥60 days after completion of first-line therapy.
• Have measurable disease defined by RECIST.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
• Have an estimated life expectancy of ≥4 weeks.
• Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.
• Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).
• Have adequate organ function.

You may not qualify if:

• Are pregnant or lactating.
• Have received prior anthracycline therapy.
• Have participated in any investigational drug study within 30 days prior to study entry.
• Have received radiotherapy within 2 weeks of treatment in this study.
• Have not recovered from acute toxicity of all previous therapy prior to enrollment.
• Have a history of a malignancy other than SCLC. Exceptions to this include: curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix, or prior low-grade, localized prostate cancer (Gleason score ≤6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.
• Have symptomatic central nervous system (CNS) metastases.
• Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances, etc.) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
• Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
• Have received radiotherapy with \>25% involvement of the bone marrow within 6 weeks prior to study start.
• Have a known hypersensitivity to doxorubicin, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N-acetyltryptophane.

Sponsors & Collaborators

• CytRx: lead

Study Sites (7)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Billings Clinic

Billings, Montana, 59107, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

Dayton Oncology and Hematology

Kettering, Ohio, 45409, United States

Location

Signal Point Hematology/Oncology, Inc.

Middletown, Ohio, 45042, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

DOXO-EMCH

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Maitland, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: May 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 9, 2012

Record last verified: 2012-02

Locations

US (7)