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Individualized (Timed) Temozolomide Administration as a Means of Immune Reconstitution in Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Melanoma, Stage IV Melanoma

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Trial Information

Individualized (Timed) Temozolomide Administration as a Means of Immune Reconstitution in Patients With Metastatic Melanoma


PRIMARY OBJECTIVES: I. To assess the clinical activity of timed administration of TMZ
therapy in patients with stage IV melanoma who have or have not received prior chemotherapy
for metastatic melanoma. SECONDARY OBJECTIVES: I. To assess the toxicity profile of
timed administration of TMZ therapy in patients with stage IV melanoma who have or have not
received prior chemotherapy for their metastatic disease. II. To evaluate the parameters of
immune homeostasis that are associated with the anti-tumor immune biorhythm in order to gain
insight into the mechanism of the observed clinical and immunological effect of timed TMZ
chemotherapy. III. To evaluate the impact of timed TMZ chemotherapy on immune biomarkers
and the anti-tumor immune biorhythms. OUTLINE: Prior to initiation of therapy patients
will undergo a period of immunologic monitoring to analyze the bioperiodicity of their
anti-tumor immune response. Patients with an established biorhythm will receive TMZ orally
(PO) starting on the recommended day for 5 days. Treatment repeats every 21-42 days (based
on the established biorhythm) until of disease progression or unacceptable toxicity.
Patients without an established biorhythm are given the option to go off study or receive
TMZ PO on days 1-5. Courses repeat every 28 days until disease progression or unacceptable
toxicity. After completion of study treatment, patients are followed up for up to 2
years.


Inclusion Criteria:



- Histologic/cytologic proof of stage IV malignant melanoma not amenable to surgery

- Any number of previous chemotherapy regimens (except those containing TMZ or
dacarbazine [DTIC]) in the metastatic setting are allowed as long as >= 4 weeks have
elapsed from last treatment

- Measurable disease defined as at least one lesion whose longest diameter can be
accurately measured as >= 1.0 cm with spiral CT scan, or ≥ 2 cm with computed
tomography (CT) component of a positron emission tomography (PET)/CT; Note: disease
that is measurable by physical examination only is not eligible

- Life expectancy of >= 3 months

- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2

- Recovered from side effects that might interfere with the protocol therapy and: - >=
4 weeks must have elapsed from last radiation treatment to time of study entry - >=
4 weeks must have elapsed from the last chemotherapy administration to time of study
entry

- Absolute neutrophil count (ANC) >= 1500/mL

- Platelet count >= 100,000/mcl

- Hemoglobin >= 9gm/mcl

- Creatinine =< 2.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) =< 3 x ULN

- Negative serum pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Ability to understand and the willingness to sign a written informed consent document

- Willingness to return to Mayo Clinic Rochester for follow-up, except for some
appointments that can be made with the local physician

- Patient willing to provide research blood samples

Exclusion Criteria:

- Receiving any other investigational agents including those for symptom management

- Uncontrolled intercurrent illness including, but not limited to, the following: -
Active infection - Congestive heart-failure (New York Heart Association [NYHA] grade
III or IV)

- Pregnant or breast feeding women, or women of child-bearing potential (and/or their
partners) who are unwilling to utilize an approved method of birth control during the
study and for 1 month afterward

- History of other malignancy < 5 years with the exception of basal cell or squamous
cell carcinoma of the skin treated with local resection only, limited stage prostate
cancer treated with surgery or radiation therapy with currently undetectable
prostate-specific antigen (PSA), or carcinoma in situ of the cervix

- Known standard therapy for the patient's disease that is potentially curative or
proven capable of extending life expectancy

- Known immunosuppression (i.e. chronic steroid use) or autoimmune disorder

- Human immunodeficiency virus (HIV) positive

- Current or known history of hepatitis

- Previous treatment with DTIC or TMZ

- Previous immunotherapy treatment for metastatic disease in the preceding 2 months;
Note: immunotherapy in the adjuvant setting is allowed

- Previously untreated brain metastases; Note: patients with previously treated brain
metastases are allowed as long as these are radiologically stable for >= 3 months and
the patient is off steroids for >= 4 weeks

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the clinical activity of timed administration of TMZ therapy in patients with stage IV melanoma

Outcome Description:

Estimated by the number of eligible patients who remain on study and have not progressed at their 4 month evaluation divided by the total number of evaluable patients; a confidence interval for the true 4 month PFS rate is constructed using the properties of the binomial distribution

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Roxana Dronca

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

MC1076

NCT ID:

NCT01328535

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

Mayo ClinicRochester, Minnesota  55905