Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 70 and under Other H8713 NCT00058825

Trial Description

Summary

Usually, patients are given very strong doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However some patients, due to complications with their condition, may have a high risk of getting possibly life-threatening treatment-related side effects. Recently, investigators have developed an increased interest in using chemotherapy that does not cause as many side effects (less toxic) before patients receive a transplant. The major problem with this type of chemotherapy is that there is a greater chance of having graft versus host disease (GVHD). GVHD occurs when the new stem cells from the donor (graft) recognizes that the body tissues of the patient (host) are different. When this happens cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.

This research study adds CAMPATH 1H to a low-dose chemotherapy regimen (the pattern that the treatment is administered) followed by allogeneic stem cell transplantation. This research study will help us learn if the addition of CAMPATH 1H to the pre-transplant low dose chemotherapy will decrease the known side effects from an allogeneic stem cell transplantation, while providing a curative treatment to patients with blood disorders and renal cell cancer.

Further Study Information

Before treatment begins, stem cells will be collected from the donor's blood or bone marrow. The stem cells will be collected and frozen before we start to give the patient chemotherapy.

After admission to the hospital, patients will receive total body irradiation (very strong type of x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the Stem cell transplant (infusion of the donors stem cells).

Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous injection until a blood test shows that granulocytes (a type of white blood cell) are more than 1000/ul. This is to help increase blood counts.

After transplantation, the patient will have several evaluations at different times. These are standard evaluations and tests done for any patient who has received a stem cell transplant as part of routine clinical monitoring:

We will also be looking at the patient's immune function (how the body protects itself to prevent and fight infections and diseases). To do this blood tests will be done at regular intervals (every 3 to 6 months) for 2 years.

Depending on how well the donors stem cells work in the body after the transplant, the patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a type of white blood cell) collected from the same donor that provided the stem cells are given to the patient through a central line into a vein.

Eligibility Criteria

Eligibility Criteria:

• Diagnosis of Myelodysplastic Disorders, Fanconi's Anemia, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell dyscrasia, Lymphoproliferative disorders (non-Hodgkin's Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia, and Hodgkin's Disease) Diagnosis of Myelodysplastic Disorders which is not good risk by IPSS, Fanconi's anemia, Acute Myelogenous Leukemia (1st or subsequent relapse or 2nd or subsequent CR or refractory disease), Acute Lymphoblastic Leukemia in 2nd or subsequent remission or relapse or refractory disease, or Philadelphia chromosome positive Chronic Myelogenous Leukemia (failed STI and interferon), Multiple Myeloma (stage II or III), Lymphoma, Chronic Lymphocytic Leukemia (primary refractory or recurrent disease), Hodgkin's Disease (after relapse) and Hemophagocytic Lymphohistiocytosis (failed chemotherapy and/or anti-viral therapy) or Metastatic Renal Cell Carcinoma.

• Conditions that increase Treatment Related Mortality (need one or more to be eligible):

• Greater or equal to 50 years of age

• EF of less than 45%

• DLCO less than 50% or FEV1 50-75% of predicted value

• Diabetes Mellitus

• Renal insufficiency (but Creatinine Clearance not less than 25 ml/min)

• Prior recent history of systemic fungal infection

• 3rd or greater remission of AML or ALL

• More than 1 year of diagnosis (CML or Myeloma patients only)

• Multiple types of treatment regimens (equal to or more than 3)

• Significant Grade III or IV neurologic or hepatic toxicity from previous treatment

• Prior Autologous or Allogeneic Stem Cell transplantation

• Haploidentical family member donor. The protocol is open to patients who lack a 5/6 or 6/6 HLA antigen matched donor. Due to the increased risk of GVHD, patients with Fanconi's anemia and a 5/6 HLA match will also be eligible. For this protocol, the "best" donor will be defined as a first-degree haploidentical family member who matches at the most MHC loci. Matching will be determined by class I and class II DNA typing. The donor should be sufficiently healthy not to be at increased risk from the mobilization procedure. Should more than one "equally" MHC incompatible donor be identified, other selection criteria will include: age and size of donor, CMV status and sex. The Principal Investigator will make final decisions.

• Available healthy donor without any contraindications for donation

• Patient and/or responsible person able to understand and sign consent

• Age between birth and 70 years.

• Women of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

• Patient is pregnant, lactating or unwilling to use contraception.

• HIV positive patient.

• Uncontrolled intercurrent infection

• Untreated Blast Crisis for CML

• Uncontrolled High-grade lymphoproliferative disease/lymphoma

• Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

• Severe chronic pulmonary disease requiring oxygen dependent (Zubrod of 3 or greater)

• Hemodialysis dependent

• Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x upper limit of normal.

• Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)

• Active CNS disease from hematological disorder.

Trial Contact Information

Trial Lead Organizations/Sponsors

Dan L. Duncan Cancer Center at Baylor College of Medicine

Malcolm K Brenner, MD

Study Director

George Carrum, MD		Ph: 713-394-6252
		Email: gcarrum@bcm.tmc.edu

U.S.A.
Texas
	Houston
	Methodist Hospital
		George Carrum, MD	Ph: 713-394-6252
			Email: gcarrum@bcm.tmc.edu
		George Carrum	Principal Investigator
	Texas Children's Hospital
		George Carrum, MD	Ph: 713-394-6252
			Email: gcarrum@bcm.tmc.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00058825
Information obtained from ClinicalTrials.gov on July 16, 2008