Know Cancer

or
forgot password

Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Stage IV Melanoma, Stage III Melanoma

Thank you

Trial Information

Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma

Inclusion Criteria


INCLUSION CRITERIA:

Pre-Treatment Phase: Tissue Procurement and Establishment of Tumor Cell Line

1. Histologic diagnosis of invasive melanoma.

2. Measurable metastatic melanoma with at least one lesion amenable to -resection
Stage III: recurrent regional disease, including regional disease with no known
primary.

Stage IV: distant metastatic melanoma.

3. Age 18 years and older.

4. Sign the "Tissue Consent", the pre-Clinical Informed Consent for Melanoma Tissue
Procurement and initiation of cell line effort granting California Stem Cell, Inc.
permission to cryopreserve the tumor and/or to initiate an autologous tumor cell line
from excess tissue that has been removed during a medical procedure (e.g., surgically
excised).

5. Initiation of Autologous Tumor Cell Line. California Stem Cell, Inc. must have
received a viable melanoma tumor tissue specimen that has been obtained and processed
according to company SOPs to ensure tissue viability. The cell line can be initiated
with either a specimen of fresh tumor or tumor that has been previously
cryopreserved.

Treatment Phase

1. Successful establishment of an autologous melanoma cell line by California Stem Cell,
Inc.

2. Patients with multiple depots of distant metastatic disease must have previously
received at least one or more of the following standard treatments: interleukin 2
(IL-2), or ipilimumab, or vemurafenib (if tumor expresses the V600E mutation), or
dacarbazine or temozolomide, if not mutated for the V600E mutation, and not felt to
be medically appropriate for IL-2 or ipilimumab. These may have been given alone, or
in combination with other agents.

3. Medical fitness to undergo a leukapheresis, including peripheral venous access or
access by central vein if necessary.

4. Medical fitness for participation in a phase III clinical trial.

- a. ECOG performance status of 0 or 1.

- b. Adequate bone marrow function: absolute neutrophil count (ANC) greater than
1000/mm (3), hematocrit greater than 30%, platelet count greater than 100,000/mm
(3), no ongoing transfusion requirements.

- c. Adequate hepatic function: total bilirubin less than 2.0 mg/dL, alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times
the upper limit of normal (ULN), albumin greater than 3 g/dL.

- d. Adequate kidney function: creatinine less than or equal to 2.0 mg/dL.

- e. Negative pregnancy test for woman of childbearing potential and use of
effective contraception (hormonal or barrier method of birth control) during
therapy (women of childbearing potential and men).

5. Extent of disease established within 4 weeks of randomization.

- a. History and Physical Exam by a licensed practitioner.

- b. Fludeoxyglucose(FDG)-based PET/CT or PET scan and CT scan.

- c. Brain MRI demonstrating no new untreated or uncontrolled metastases.

6. Recovery from previous therapies.

- a. At least four weeks (28 days) must have elapsed since any prior systemic
therapy at the time of the first dose (six weeks for anti-cytotoxic T
lymphocyte-associated antigen 4 (anti-CTLA-4), and any toxicities experienced
must have recovered to a grade 1 or less (except for alopecia or vitiligo).

- b. More than three weeks (at least 22 days) since radiation therapy at the time
of the first dose (7 days for single-dose stereotactic radiotherapy such as
gamma knife) and recovery from acute toxicities. Patients treated with whole
brain radiation must wait at least 22 days after completion of radiation and
have radiographic confirmation of lack of progression before proceeding to
randomization.

EXCLUSION CRITERIA:

Pre-Treatment Phase: Tissue Procurement and Establishment of Tumor Cell Line

1. Eastern Cooperative Oncology Group (ECOG) performance status greater than 2

2. Lack of a metastatic melanoma lesion that can be resected.

Treatment Phase

1. Known positive for hepatitis B or C or HIV.

2. Pregnant or lactating women.

3. Underlying cardiac disease associated with known myocardial dysfunction, or active
treatment with digoxin or other medications being given to treat heart failure, or
unstable angina related to atherosclerotic cardiovascular disease.

4. Diagnosis of any other invasive cancer that requires ongoing treatment or for which
there is evidence of active disease.

5. Active, unresolved infection and/or receiving concurrent treatment with parenteral
antibiotics (patients are eligible after antibiotics have been discontinued for at
least 7 days prior to first dose and evidence of infection has resolved).

6. Other active medical condition that could be imminently life threatening, in the
opinion of the investigator, including no active blood clotting or bleeding
diathesis.

7. New or uncontrolled brain metastases or leptomeningeal disease and/or taking
pharmacological doses of corticosteroids. Brain metastases treated by gamma knife or
stereotactic radiotherapy are considered controlled, unless patient requires
pharmacologic doses of corticosteroids. It is recognized that tumor necrosis may be
confused with tumor progression in interpretation of Brain MRI.

8. Known autoimmune disease, immunodeficiency, or disease process that involves the use
of immunosuppressive therapy.

9. Taking other anticancer therapy.

10. Received another investigational drug within 28 days of the first dose.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The time frames are estimated time in months (rounded up to the nearest month) from the start of study. The time estimates for the analyses are based on enrolling approximately 250 patients over a 34.8 months period and having a follow up of approximately 17 months after the last patient is enrolled.

Outcome Time Frame:

52 months

Safety Issue:

No

Principal Investigator

Robert Dillman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

California Stem Cell, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CL-CA-P01-00-US

NCT ID:

NCT01875653

Start Date:

March 2014

Completion Date:

June 2017

Related Keywords:

  • Stage IV Melanoma
  • Stage III Melanoma
  • metastatic melanoma
  • dendritic cells
  • immunotherapy
  • Granulocyte-Macrophage Colony Stimulating Factor
  • overall survival
  • autologous
  • peripheral blood mononuclear cells
  • treatment
  • phase 3
  • tumor cells
  • Melanoma

Name

Location

Hoag Memorial PresbyterianNewport Beach, California  92658