Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors

NCT00352131 | Completed Phase 1

• 4 other identifiers: CDR0000491224IMMUNO-101IMMUNO-045-5011-228UTHSC-IDD-0504
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.

Conditions

Non-colorectal Cancer; Pancreatic Cancer

Keywords

unspecified adult solid tumor, protocol specific; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

  for the duration of the trial

• Maximum tolerated dose

  for the duration of the trial

Secondary Outcomes (3)

• Toxicity

  for the duration of the trial

• Pharmacokinetics

  for the duration of the trial

• Antitumor activity

  for the duration of the trial

Interventions

HuC242-DM4 DRUG

Dose escalation study to define maximum tolerated dose. Doses will vary per cohort. Patients will receive an IV infusion once every three weeks.

Also known as: IMGN242

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Inoperable or metastatic disease * Failed standard therapy * Confirmed cancer antigen (CanAg) expression * Patients must have non-colorectal cancer or pancreatic cancer * Tumor must have a homogeneous pattern (i.e., staining present in \> 75% of tumor cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry \* No known leptomeningeal disease or progressive brain disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL (transfusion allowed) * Platelet count ≥ 100,000/mm³ * aPTT and INR ≤ 1.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 60 mL/min * Bilirubin ≤ 1.5 mg/dL * AST and ALT \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * No hypersensitivity to agents of the same class as the study drug, humanized or nonhumanized antibodies, or immunoconjugates * No active, uncontrolled infection * No hepatitis B surface antigen or hepatitis C antibody positivity * No history of alcoholic liver disease * No serious medical or psychiatric disorder that would preclude compliance with study requirements * No peripheral neuropathy \> grade 1 * No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer * No severe concurrent disease or condition that, in the opinion of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) * At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for cancer * At least 4 weeks since prior major surgery * No concurrent chemotherapy, other immunotherapy, radiotherapy, or other investigational therapy * Palliative radiotherapy for related bone metastases allowed * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (2)

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

UT Health Science Center

San Antonio, Texas, 78245-3217, United States

Location

Related Publications (1)

• Sankhala KK, Mita AC, Ricart AD, et al.: A phase I and pharmacokinetic study of a CanAg-targeted immunoconjugate, HuC242-DM4, in patients with CanAg-expressing solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B70, 2007.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alain Mita, MD

  Institute for Drug Development

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: February 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 17, 2010

Record last verified: 2010-03

Locations

US (2)