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

Melanoma Clinical Trial

Official title:

Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580320
• Other study ID #: MCC-03740
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2007
• Last updated: August 17, 2016
• Start date: September 2004
• Est. completion date: November 2013

Study information

• Verified date: August 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2013
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoid Tumors
• Carcinoma
• Carcinoma, Small Cell
• Lung Neoplasms
• Melanoma
• Neuroendocrine Tumors
• Parathyroid Carcinoma
• Parathyroid Neoplasms
• Sarcoma
• Small Cell Carcinoma of the Lung
• Small Cell Lung Carcinoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Dacarbazine and bortezomib
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

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Massey Cancer Center/Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by serious adverse events		4 years	Yes

External Links

•   Publication