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: June 9, 2014
Last verified: June 2014
  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 ]

Enrollment: 55
Study Start Date: July 2009
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:
  • CDK inhibitor SCH 727965
  • cyclin-dependent kinase inhibitor SCH 727965
  • SCH 727965

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
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: NCT00937937

  Show 174 Study Locations
Sponsors 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, NCI-2011-01935, SWOG-S0826, CDR0000647155, S0826, S0826, U10CA032102
Study First Received: July 10, 2009
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Hutchinson's Melanotic Freckle
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Cyclin-Dependent Kinase Inhibitor Proteins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014