Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003850
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: January 2001
  Purpose

Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.


Condition Intervention Phase
Head and Neck Cancer
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Thalidomide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 47
Study Start Date: April 1999
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.
Drug: thalidomide

Detailed Description:

OBJECTIVES:

I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.

OUTLINE:

Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven squamous cell carcinoma of the head and neck
  • Recurrent disease OR metastatic disease at initial diagnosis or at recurrence
  • Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
  • No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
  • Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: Zubrod 0-2
  • Life expectancy: At least 3 months
  • WBC at least 3000/mm3
  • Platelet count at least 100,000/mm3
  • Hematocrit at least 30%
  • Bilirubin no greater than 1.5 times normal
  • SGOT/SGPT no greater than 1.5 times normal
  • Creatinine no greater than 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study
  • Men must use effective barrier contraception during and for 1 month after study
  • No grade 2 or greater peripheral neuropathy
  • No serious infection or other concurrent illness requiring immediate therapy
  • Must be able to take oral medications
  • No medical or social factors that would interfere with compliance

PRIOR CONCURRENT THERAPY:

  • Any number of courses of one regimen of chemotherapy allowed
  • No concurrent cytotoxic chemotherapy
  • No concurrent radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003850

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003850     History of Changes
Other Study ID Numbers: NCI-2012-02299, MDA-ID-98270, NCI-T98-0074, CDR0000067011
Study First Received: November 1, 1999
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014