Trial record 2 of 9 for:
"Acral lentiginous melanoma"
Dinaciclib in Treating Patients With Stage IV Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00937937
First received: July 10, 2009
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
| Condition | Intervention | Phase |
|---|---|---|
|
Acral Lentiginous Malignant Melanoma Lentigo Maligna Malignant Melanoma Mucosal Melanoma Nodular Malignant Melanoma Recurrent Melanoma Stage IV Melanoma Superficial Spreading Malignant Melanoma |
Drug: dinaciclib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Response rate (confirmed and unconfirmed complete and partial responses) assessed by RECIST [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: dinaciclib
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.
SECONDARY OBJECTIVES:
I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.
III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.
OUTLINE: This is a multicenter study.
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Biopsy-confirmed malignant melanoma
- Stage IV disease
- Cutaneous or mucosal origin
- Melanoma of unknown primary allowed
- No ocular melanoma
- Measurable or non-measurable disease
- No prior or concurrent brain metastases as confirmed by CT scan or MRI
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases)
- SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
- Serum creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
- No prior therapy with a cyclin-dependent kinase inhibitor
- At least 14 days since prior radiotherapy
- At least 28 days since prior systemic chemotherapy
- At least 28 days since prior adjuvant systemic therapy
- At least 28 days since prior surgery
- No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy
- Therapy for stage IV resected free-of-disease will be considered adjuvant therapy
- Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1
- Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1
- No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
- No concurrent CYP3A4 inhibitors or inducers
- No concurrent grapefruit or grapefruit juice
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937937
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Show 175 Study LocationsSponsors and Collaborators
Investigators
| Principal Investigator: | Christopher Lao | Southwest Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00937937 History of Changes |
| Other Study ID Numbers: | NCI-2011-01935, S0826, SWOG-S0826, CDR0000647155, U10CA032102 |
| Study First Received: | July 10, 2009 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lentigo Melanoma Hutchinson's Melanotic Freckle Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclin-Dependent Kinase Inhibitor Proteins Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013