Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Thalidomide

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age > 18 years
2. Histologically/laparoscopically confirmed endometriosis
3. Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months
4. VAS of 6 or more at baseline
5. Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)
6. Patients must give written informed consent.
7. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

1. Pregnant and/or lactating female
2. Users of other angiogenesis inhibitors
3. Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy
4. Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months
5. Use of norethindrone acetate (Aygestin) in the prior month
6. Seizure disorder
7. Hepatitis, or any active infection (upper respiratory infection, PID, etc)
8. History of thromboembolic disease.
9. Baseline neutropenia (ANC < 1000/mm^3)
10. Any severe physical or metal illness that would interfere with the completion of the protocol
11. Illicit drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thalidomide; Thalidomide was administered and pain reports were recorded over the course of 6 months.	Drug: Thalidomide; Pill form, 50mgs with increasing dosage up to a maximum of 250 mg qd based on pain reports, taken once daily for 14-16 weeks with one 6 month follow-up appointment.; Other Names: Thalomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain report	6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Celgene Corporation
• Investigators: Principal Investigator: Denniz Zolnoun, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 20, 2011
• Last Update Submitted That Met QC Criteria: December 19, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: 65681