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Study Summary
No. ID03-0090:.......Melanoma......Wen-Jen Hwu......Melanoma Medical Oncology
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Study Summary Title
Study Summary
Number:
ID03-0090
Study Title:A PHASE 1, OPEN LABEL, NON-RANDOMIZED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, IMMUNE FUNCTION EFFECTS, AND EFFICACY OF MULTIPLE DOSES OF CP-675,206 IN PATIENTS WITH ADVANCED MELANOMA, AND PHASE 2, OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS, OF 2 REGIMENS OF CP-675,206 IN PATIENTS WITH ADVANCED MELANOMA
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Physician New Patient Referral
Name:Wen-Jen HwuPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Melanoma Medical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2921
Contact us about clinical trials
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General Information
Disease Group:MelanomaSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Intravenous infusion of CP-675,206 will be on Day 1 of every cycle, every 28
days. Subjects may still be treated in the absence of progression or toxicity
for a maximum of 12 cycles or up to the "tolerable duration of exposure",
whichever is shorter.
Treatment
Agents:
206
CP-675
Home Care:NOT APPLICABLE.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
No hospitalization is required.
Description/
Intervention:
There are three parts to this clinical research study. The goal of the first
part of the study is to find a safe dose of the new drug CP-675,206. The goal
of the second part of the study is to learn what effects (good and bad) the
dose found in the first part of the study has when given to patients with
melanoma. The goal of the third part of the study is to learn if the dose
level found in the first part of the study can help to shrink or slow the
growth of the cancer in patients with melanoma. You are being asked to
participate only in the third part of the study, learning if the dose of
CP-675,206 that was found in the first part of the study can help to shrink or
slow the growth of the cancer in patients with melanoma.
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Study Objectives / Outcomes
Phase 1 Objectives

Primary Objectives:
  • To assess the safety and tolerability of escalating doses of CP-675,206 and to
    determine the pharmacokinetic-based recommended Phase 2 dose of intravenous CP-675,206 administered every 28 days to subjects with advanced melanoma.
  • To assess the biological activity of CP-675,206 as measured by staphylococcal
    enterotoxin A superantigen (SEA) assay, major histocompatibility complex (MHC)
    tetramer assay and enzyme-linked immunospot (ELISPOT) assay at the recommended phase 2 dose.

Secondary Objectives:
  • To determine the multiple dose pharmacokinetic (PK) profile of CP-675,206.
  • To monitor for human anti-human antibodies (HAHA) and cytokine release.
  • To explore whether the CTLA4 genotype influences the safety and/or immune response of subjects treated with CP-675,206.
  • To document any preliminary evidence of clinical efficacy.

Phase 2 Objectives

Primary Objective:
  • To assess the efficacy of intravenous CP-675,206 administered on a dose of 10 mg/kg
repeated every 28 days, or as a single dose of 15 mg/kg as determined by objective
response rate in patients with advanced melanoma

Secondary Objectives:
  • To assess clinical efficacy as measured by clinical benefit response rate, duration of
response, time to progression, and survival
  • To further characterize the safety profile and tolerability of CP-675,206 in these settings
  • To identify any predictive relationship between CP-675,206 pharmacokinetics and
toxicity and efficacy
  • To explore health-related quality-of-life outcomes (HQoL) in both treatment arms
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Study Status Information
Study Activation / Registration Date:08/04/2003
IRB Review and Approval Date:04/30/2003
Study Type:
Recruitment Status:Terminated
Projected Accrual:86
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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) Histologically documented stage III unresectable melanoma or stage IV (AJCC 6th edition) melanoma (patients with melanoma of ocular origin will not be eligible).

2) Documented progressive disease following therapy for metastatic disease. Patients not previously treated for metastatic disease will not be eligible duiring the phase 2 portion of the study.

3) Measurable disease as defined by RECIST. (Section 3.3.5. of the protocol)

4) ECOG performance status of 0 or 1 (see Appendix H) with a life expectancy of > 3 months.

5) Either gender, aged 18 years and above.

6) Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy, defined as: a)Absolute neutrophil count >/= 1.5 x 10 9 cells/L; b) Platelets >/=100 x 10 9 /L; c) Aspartate and alanine aminotransferases (AST, ALT) </= 2.5 x ULN (< 5 x ULN, if documented liver metastases are present); d) Total bilirubin </=1.5 x ULN; e) Creatinine </=1.5 x ULN.

7) Subjects must have recovered from all prior treatment related toxicities, to baseline status, or a CTC grade of 0 or 1. Post-surgical pain shall not be considered a basis for exclusion.

8) Concurrent or subsequent hormonal therapy is allowed.

9) Females must either be not of childbearing potential [surgically sterilized, which includes tubal ligation, or at least 2 years postmenopausal; not breastfeeding], or practicing 1 form of approved contraception for at least three months prior to entry into the study with 1 of the following methods: a) oral contraceptives; b) Intrauterine device; c) implanted contraceptive; d) injected contraceptives; e) diaphragm; f) sexual partner must use condom or be surgically sterilized; g) sexually inactive.Females must avoid pregnancy. Negative pregnancy test must be documented during screening.

10) Must be willing and able to provide written informed consent.

11) For subjects enrolled ONLY in the expansion portion of the study, presence of HLA tissue subtype, A*0201.

Exclusion Criteria:1) Received immunotherapy for cancer within one month prior to the start of screening.

2) Received >2 doses of previous CP-675,206.

3) Patients previously treated on this protocol.

4) History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (e.g., Addison's disease, asthma, celiac disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc.).

5) Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history.

6) History of autoimmune colitis or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.

7) Pregnant or lactating women (see Section 3.1.1, criteria 10).

8) Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.

9) Diagnosed or suspected brain metastases. Patients with past history of brain metastases but with no radiologic evidence within 12 weeks prior to enter into the protocol will be eligible.

10) Any serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment.

11) Coexisting malignancies except for basal or squamous cell carcinoma of the skin.

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Links
Registration Number: NCT00086489
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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