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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma, Small Cell Carcinoma of the Lung, Carcinoid Tumors

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety as measured by serious adverse events

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Andrew Poklepovic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MCC-03740

NCT ID:

NCT00580320

Start Date:

September 2004

Completion Date:

October 2013

Related Keywords:

  • Melanoma
  • Soft Tissue Sarcoma
  • Parathyroid Carcinoma
  • Small Cell Carcinoma of the Lung
  • Carcinoid Tumors
  • melanoma
  • soft tissue sarcoma
  • APUD tumor
  • dacarbazine
  • bortezomib
  • velcade
  • Carcinoid Tumor
  • Carcinoma
  • Lung Neoplasms
  • Melanoma
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell
  • Parathyroid Neoplasms
  • Sarcoma

Name

Location

Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Massey Cancer Center/Virginia Commonwealth UniversityRichmond, Virginia  23298