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Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Primary Purpose

Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dacarbazine and bortezomib
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring melanoma, soft tissue sarcoma, APUD tumor, dacarbazine, bortezomib, velcade

Eligibility Criteria

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

Inclusion Criteria:

  • Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
  • Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
  • Age 18 years or greater
  • ECOG Performance Status 0 or 1
  • Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.

Exclusion Criteria:

  • Uncontrolled brain metastatic disease
  • Platelet count <100
  • Absolute neutrophil count <1.5
  • Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
  • Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
  • AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal
  • Bilirubin > 2 mg/mL
  • Grade 2 or greater peripheral neuropathy
  • Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
  • Pregnant or nursing
  • Other investigational drugs within 14 days of enrollment
  • Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study

Sites / Locations

  • Dartmouth Hitchcock Medical Center
  • Massey Cancer Center/Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

dacarbazine + bortezomib

Outcomes

Primary Outcome Measures

Safety as measured by serious adverse events

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
August 17, 2016
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00580320
Brief Title
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Official Title
Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.
Detailed Description
The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly. Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma, Small Cell Carcinoma of the Lung, Carcinoid Tumors
Keywords
melanoma, soft tissue sarcoma, APUD tumor, dacarbazine, bortezomib, velcade

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
dacarbazine + bortezomib
Intervention Type
Drug
Intervention Name(s)
Dacarbazine and bortezomib
Other Intervention Name(s)
bortezomib (velcade)
Intervention Description
Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
Primary Outcome Measure Information:
Title
Safety as measured by serious adverse events
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma. Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy. Age 18 years or greater ECOG Performance Status 0 or 1 Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment. Exclusion Criteria: Uncontrolled brain metastatic disease Platelet count <100 Absolute neutrophil count <1.5 Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment. Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal Bilirubin > 2 mg/mL Grade 2 or greater peripheral neuropathy Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine Pregnant or nursing Other investigational drugs within 14 days of enrollment Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Poklepovic, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Massey Cancer Center/Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3618599/
Description
Publication

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Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

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