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Study Summary
No. 2003-0964:.......Myeloma......Michael Wang......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2003-0964
Study Title:An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients with Refractory or Relapsed Multiple Myeloma
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Physician New Patient Referral
Name:Michael WangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:N/A
Phase of Study:Phase IReturn
Visit:
Patients are to return to the clinic 7 times after initial dose. If patients
are eligible, return visits are up to a total of 12, one visit per cycle. If
they discontinue or finish the study, patients will return for an additional
followup visit.
Treatment
Agents:
Atiprimod
Ursodiol
Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out how safe atiprimod and
atiprimod in combination with ursodiol are as a potential treatment for
patients with refractory or relapsed multiple myeloma. This will include
trying to find the highest dose of atiprimod and atiprimod in combination with
ursodiol that can be safely given without causing severe side effects.
Researchers will find out what happens to atiprimod and to atiprimod in
combination with ursodiol once it enters the body by measuring the levels of
atiprimod and of atiprimod in combination with ursodiol in the blood at various
times during the study. Researchers will study the ability of atiprimod and
atiprimod in combination with ursodiol to stop the growth and spread of cancer.
Researchers will also find out if patients can be safety treated with higher
doses of atiprimod when it is given in combination with ursodiol compared to
when it is given alone. Researchers will also identify substances in blood,
urine, and/or bone marrow that may help to better understand how atiprimod and
atiprimod in combination with ursodiol works.
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Study Objectives / Outcomes
The primary objectives of this study are 1) to identify the maximum tolerated dose (MTD) and to evaluate the safety of atiprimod when given in doses starting at 30 mg/day and ranging to 480 mg/day, or the MTD, whichever is lower, in patients with refractory or relapsed multiple myeloma, 2) to identify the MTD and to evaluate the safety of atiprimod when given in combination with ursodiol in doses starting at 180 mg/day atiprimod and ranging to 480 mg/day atiprimod, or the MTD, whichever is lower, in patients with refractory or relapsed multiple myeloma, and 3) to compare the safety of atiprimod when given alone and in combination with ursodiol in patients with refractory or relapsed multiple myeloma.

The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod in patients with refractory or relapsed multiple myeloma, 2) to measure the pharmacokinetics of atiprimod when given in combination with ursodiol in patients with refractory or relapsed multiple myeloma, 3) to evaluate response to atiprimod in patients with refractory or relapsed multiple myeloma, and 4) to evaluate response to atiprimod when given in combination with ursodiol in patients with refractory or relapsed multiple myeloma.
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Study Status Information
Study Activation / Registration Date:03/30/2004
IRB Review and Approval Date:02/04/2004
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:up to 105
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patient must have documented history of multiple myeloma diagnosis, and must have failed or relapsed following an adequate trial of at least 2 regimens for multiple myeloma, including high dose corticosteroids.

2) Age 18 years or older.

3) Bisphosphonates for multiple bone lesions is allowed, but patient must not be receiving corticosteroids or other chemotherapy, thalidomide, or other investigational agents, within 30 days prior to the first dose of investigational drug.

4) All necessary screening evaluations for determining eligibility must be obtained within 14 days prior to enrollment.

5) ECOG (Zubrod) performance status of 0 to 2.

6) Must adhere to visit schedule and other protocol requirements.

7) Must understand and sign informed consent.

8) Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria:1) Renal insufficiency, serum creatinine levels of more than 2 mg/dl.

2) Concomitant therapy that includes corticosteroids or other chemotherapy that is or may be active against myeloma.

3) Peripheral neuropathy of Grade 3 or greater assessed by a directed neurologic examination, including light touch, pinprick, proprioception, and deep tendon reflexes (DTR) of the upper and lower extremities; and questioning for symptoms of paresthesia and numbness (FACT/GOG-Ntx).

4) Patients with evidence of mucosal or internal bleeding.

5) Patients with a platelet count of < 50,000 cells/mm3.

6) ANC of less than 1000 cells/mm3.

7) ALT or AST levels equal or more than 2 times the upper limit of normal (ULN).

8) Any condition which, in the opinion of the PI, places the patient at unacceptable risk if he/she were to participate in the study.

9) Clinically relevant active infection or serious co-morbid medical conditions.

10) Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 3 years.

11) If WCBP, pregnant, lactating, or not using adequate contraception.

12) As atiprimod is a potent inhibitor of CYP2D6, patients taking drugs that are substrates of 2D6 (e.g. beta blockers, antidepressants, and antipsychotics; see Appendix H) will be excluded from the study.

13) Patients with nonsecretory myeloma.

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Links
Registration Number: NCT00086216
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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