Safety Study Using Weekly Infusions of BB-10901 in Patients With Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I, Open-Label, Dose Escalation Study of Weekly Dosing With BB-10901, Followed by a Phase II Efficacy Expansion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065429
• Other study ID #: C10/IVB/001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 23, 2003
• Last updated: July 9, 2012
• Start date: April 2003
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: ImmunoGen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.

Description:

The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).

Other known NCT identifiers

• NCT00074256

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• Histologically or Cytologically proven SCLC, CD 56+ small cell carcinoma of unknown origin, or CD56+ non-pulmonary small cell carcinoma

• Relapsed disease; defined as patients with an initial response (partial or complete) to first-line therapy, then relapse more than 3 months after completion of last chemotherapy.

• Patients must have received no more than 3 prior chemotherapy regimen.

• Patients must have measurable disease defined as: Lesions that can be measured in at least one dimension according to RECIST

• Predicted survival of 3 months or more

• Zubrod performance status 0-2

• Patients must not have received chemotherapy or radiation therapy within 4 weeks of study entry, nor have planned surgery.

• Absolute neutrophils greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 9g/dl and platelets greater than or equal to 100 x 10^9/l.

• Creatinine less than or equal to 1.5 times the upper limit of normal

• AST/ALT less than or equal to 3 times the upper limit of normal without liver metastases; less than or equal to 5 times the upper limit of normal with liver metastases and bilirubin less than or equal to 1.5 times the upper limit of normal.

• Patients must have normal thyroid function (patients receiving thyroxin replacement therapy who are biochemically euthyroid may be enrolled).

• Women of childbearing potential must provide a negative pregnancy test at screening and use adequate contraception in the opinion of the investigator, for the duration of study.

• Patients must be capable of understanding the nature of the trial and must give written witnessed informed consent prior to any screening procedure.

Exclusion:

• Significant residual neurological or cardiac toxicity (grade 3 or 4) following previous chemotherapy

• Patients who are concurrently receiving other anti-neoplastic treatment (chemotherapy, radiotherapy, or immunotherapy including steroid therapy).

• Myocardial infarction within 6 months of study entry, unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled arrythmia, severe aortic stenosis, a history of multiple sclerosis, or other demyelinating disease, Eaton-Lambert Syndrome, history of hemorrhagic stroke, any CNS injury with residual neurologic deficit, ischaemic stroke within the last 6 months, current known herpes zoster (shingles), or cytomegalovirus infection, or a history of recurrent infections with these viruses, chronic alcoholism, serious concomitant infection, or any other concomitant illness considered significant enough to interfere with the study outcome.

• Other investigational agents must not be taken during the study or within 4 weeks of study entry.

• Previous monoclonal antibody therapy

• Patients must not have known central nervous system metastases

• Previous malignancy with < 5 year disease free interval from the last therapeutic intervention, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.

• Patient unwilling or unable to tolerate and comply with the requirements of the study.

• Pregnant or lactating females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• BB-10901
I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.

Locations

Country	Name	City	State
United States	New York Oncology Hematology	Albany	New York
United States	The Ohio State University	Colombus	Ohio
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Cancer Center of Florida	Ocoee	Florida
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoGen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)	Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia = 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.	every 6 weeks	Yes
Primary	Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]	Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions	6 weeks	No