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 22, 2016
Last verified: June 2016
  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 Melanoma
Lentigo Maligna Melanoma
Mucosal Melanoma
Nodular Melanoma
Recurrent Melanoma
Stage IV Skin Melanoma
Superficial Spreading 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: Weekly, up to 3 years ] [ Designated as safety issue: No ]
    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.


Secondary Outcome Measures:
  • Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Disease assessment was performed every 6 weeks, up to 3 years. ] [ Designated as safety issue: No ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.

  • Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST [ Time Frame: Disease assessments for response were performed every 6 weeks, up to 3 years ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  • Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [ Time Frame: Toxicity assessment was evaluated after each cycle (21 days), up to 3 years. ] [ Designated as safety issue: No ]
    Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.


Enrollment: 72
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
  • MK-7965
  • 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   (Adult, Senior)
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 177 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christopher Lao Southwest Oncology Group
  More Information

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
Results First Received: October 22, 2015
Last Updated: June 22, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Lentigo
Hutchinson's Melanotic Freckle
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2016