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Dinaciclib in Treating Patients With Stage III-IV Melanoma

Primary Purpose

Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dinaciclib
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IIIB Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically confirmed, unresectable stage III or stage IV malignant melanoma
  • ECOG performance status =< 1
  • Absolute neutrophil count >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT =< 1.5 x institutional upper limit of normal
  • Creatinine =< 1.5 mg/dl OR
  • Creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Eligible patients must agree to pre- and post-treatment biopsies of normal skin; in the phase 1 part of the study, patients with cutaneous disease or accessible lymph nodes must also agree to pre- and post-treatment tumor biopsies; in the phase 2 part of the study, tumor biopsies are required of the first 20 patients enrolled who have cutaneous disease or accessible lymph nodes
  • Patients enrolled to the Phase 2 portion of the study must have measurable disease by RECIST criteria
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients with active CNS metastases are excluded; patients with a history of CNS metastases that have been treated must be stable for 4 weeks after completion of treatment, with image documentation required; patients must not be taking enzyme-inducing anticonvulsants and must be either off steroids or be receiving a stable dose of steroids
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SCH727965
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SCH727965; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Patients with other currently active malignancies are excluded, except those with an in-situ cancer or basal or squamous cell carcinoma of the skin
  • In the phase 2 part of the study, patients who have received prior investigational treatment with a cdk inhibitor are excluded

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (dinaciclib)

Arm Description

Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

Outcomes

Primary Outcome Measures

Recommended Phase-2 Dose of SCH727965
Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Percentage of Patients Alive (Phase II)
Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II

Secondary Outcome Measures

Progression-free Survival

Full Information

First Posted
December 3, 2009
Last Updated
March 3, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01026324
Brief Title
Dinaciclib in Treating Patients With Stage III-IV Melanoma
Official Title
A Phase 1/2 Study of SCH727965 in Patients With Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2009 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This is a phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose of SCH727965 administered as a 4-hour infusion every other week in patients with advanced malignant melanoma. (Phase I) II. To determine the 1-year overall survival of patients with malignant melanoma treated with SCH727965 at the dose and schedule derived in the phase 1 part of the study. (Phase II) SECONDARY OBJECTIVES: I. To characterize the safety profile and toxicities of SCH727965 administered as a 4-hour infusion every other week. II. To determine the pharmacokinetics of SCH727965 administered as a 4-hour infusion every other week. III. To determine the proportion of patients with malignant melanoma who are alive without progression of disease 6 months after beginning treatment with SCH727965 at the dose and schedule derived in the phase 1 part of the study. IV. To determine the objective response rate to SCH727965 of patients with malignant melanoma enrolled to part 2 of the study. V. To document cdk2, combined cdk2/1 and cdk9 inhibition in surrogate tissues and tumor. VI. To correlate the degree of change of pharmacodynamic parameters in post-treatment compared to pre-treatment samples with clinical outcome. VII. To correlate the degree of change of parameters defining cdk2, cdk2/1 and cdk9 inhibition with pharmacokinetic parameters. VIII. To correlate pre-treatment cdk2 levels with the degree of change of parameters measuring cdk2 inhibition. IX. To correlate pre-treatment cdk2 levels with clinical outcome. X. To correlate tumor p53 status with clinical outcome. OUTLINE: This is a phase I dose-escalation study followed by a phase II study. Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (dinaciclib)
Arm Type
Experimental
Arm Description
Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
dinaciclib
Other Intervention Name(s)
CDK inhibitor SCH 727965, cyclin-dependent kinase inhibitor SCH 727965, SCH 727965
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Recommended Phase-2 Dose of SCH727965
Description
Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.
Time Frame
14 days
Title
Percentage of Patients Alive (Phase II)
Description
Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed, unresectable stage III or stage IV malignant melanoma ECOG performance status =< 1 Absolute neutrophil count >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT =< 1.5 x institutional upper limit of normal Creatinine =< 1.5 mg/dl OR Creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Eligible patients must agree to pre- and post-treatment biopsies of normal skin; in the phase 1 part of the study, patients with cutaneous disease or accessible lymph nodes must also agree to pre- and post-treatment tumor biopsies; in the phase 2 part of the study, tumor biopsies are required of the first 20 patients enrolled who have cutaneous disease or accessible lymph nodes Patients enrolled to the Phase 2 portion of the study must have measurable disease by RECIST criteria Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier Patients may not be receiving any other investigational agents Patients with active CNS metastases are excluded; patients with a history of CNS metastases that have been treated must be stable for 4 weeks after completion of treatment, with image documentation required; patients must not be taking enzyme-inducing anticonvulsants and must be either off steroids or be receiving a stable dose of steroids Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SCH727965 HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SCH727965; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Patients with other currently active malignancies are excluded, except those with an in-situ cancer or basal or squamous cell carcinoma of the skin In the phase 2 part of the study, patients who have received prior investigational treatment with a cdk inhibitor are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hodi
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Dinaciclib in Treating Patients With Stage III-IV Melanoma

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