Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Alemtuzumab

Pentostatin

Antineoplastic Agents, Immunological

Adenosine

Enzyme Inhibitors

Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks

4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks

Farhad Ravandi-Kashani, MD

The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.

Alemtuzumab is an antibody protein that is directed towards a marker molecule on the surface of both B- and T- lymphoid cells. It is currently approved for use in treating patients with chronic lymphocytic leukemia and has been studied in treating patients with a number of T-cell malignancies. Alemtuzumab has been found to be effective in these conditions. Pentostatin is a drug that is approved for treating patients with hairy cell leukemia, a B-cell malignancy. Pentostatin has also been studied in a number of T-cell cancers and has been found to be effective. The purpose of this study is to see whether combining these drugs will prove to be more effective.

If you are found to be eligible to take part in this study, you will receive pentostatin through a central venous catheter in your vein once a week for 4 weeks and then every 2 weeks until the achievement of best response. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail and you will be required to sign a separate consent form for this procedure.

Alemtuzumab will also be given through a vein catheter on Days 1, 2, and 3. The dose of alemtuzumab that you receive will be increased each day for the first 3 days to make sure that you tolerate it. It will then be given three times per week until you achieve the best response. If you develop reactions to alemtuzumab when given through a vein, you may receive it by injections of the same dose under the skin.

During the treatment, you will have blood (about 2 tablespoons) drawn once a week for the first 4 weeks for routine blood tests. These blood tests will then be repeated every 2 to 4 weeks for the remainder of the study. At the end of treatment a bone marrow examination will be repeated to document your response. Also, if you had a chest X-ray or CT scans, these will be repeated to confirm your level of response.

The maximum amount of time that alemtuzumab will be given is 3 months. The maximum amount of time that pentostatin will be given is 6 months. You may be able to receive the treatment will your local oncologists. However, you will have close follow-up at M. D. Anderson. You will be taken off this treatment if the disease gets worse during treatment or if unacceptable side effects develop.

You will be continued to be followed either directly or by telephone to evaluate your long-term response to treatment on this study.

This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

This is an investigational study. Both alemtuzumab and pentostatin are commercially approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Alemtuzumab and Pentostatin In T-cell Neoplasms

A Phase II Study of Alemtuzumab and Pentostatin In T-Cell Neoplasms

Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.

Astex Pharmaceuticals, Inc.

Bayer

M.D. Anderson Cancer Center

Alemtuzumab + Pentostatin

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Farhad Ravandi-Kashani MD/Associate Professor

Complete Response

Partial Response

Number of Participants With Objective Response

Overall Study

Infections

Symptoms and General Pathology

Leukemia, Lymphoid

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Leukemia, Lymphocytic, Chronic, B-Cell

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphoma, Non-Hodgkin

Peripheral T-cell Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Cutaneous T-cell Lymphoma

Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.

Deoxycoformycin (DCF)

Razelle Kurzrock, MD

The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.

Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.

A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies

A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies

Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).

Recurrence

Leukemia, Myeloid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Blast Crisis

Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cordycepin

Clotrimazole

Miconazole

Antifungal Agents

Dose escalation for deoxycoformycin and cordycepin

Dose escalation study using the following doses:

6mg/m2, 12 mg/m2, 24mg/m2, 48mg/m2

Dose escalation using the Fibonacci dose escalation sequence starting dose 2mg/m2, escalating to 3mg/m3 intravenous

Deoxycoformycin

Timothy J. Ernst, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.

OBJECTIVES: I. Evaluate the safety, maximum tolerated dose, adverse effects, and toxicities of cordycepin, given 1 hour following a fixed dose of the adenosine deaminase inhibitor pentostatin, in patients with refractory TdT positive leukemia. II. Determine the single and multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of pentostatin. III. Characterize selected whole blood and blast cell metabolic parameters serially in relation to cordycepin/pentostatin administration. IV. Measure and quantify any clinical responses in refractory TdT positive leukemia patients following cordycepin/pentostatin administration.

OUTLINE: This is a dose escalation study. Each treatment course is 28 days in length. On days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by a 1 hour infusion of cordycepin IV. An escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed. After this is determined, a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose (MTD) when given in combination with pentostatin. The MTD is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued.

Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia

A Phase I Study of Cordycepin (NSC 63984) Plus 2'-Deoxycoformycin (NSC 218321) in Patients With Refractory TdT-Positive Leukemia

Dose limiting toxicities will be assessed within the first 28 days of study drug

National Cancer Institute (NCI)

Boston Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alemtuzumab and Pentostatin In T-cell Neoplasms	NCT00453193	Lymphoma Leukemia	Pentostatin Alemtuzumab	18 Years -	M.D. Anderson Cancer Center
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies	NCT00038025	Peripheral T-ce... Cutaneous T-cel... Chronic Lymphoc...	Deoxycoformycin...	16 Years -	M.D. Anderson Cancer Center
Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia	NCT00003005	Leukemia	Cordycepin Deoxycoformycin	18 Years -	Boston Medical Center

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