## Protocol Section
### Identification Module
**NCT ID:** NCT00073879

**Brief Title:** Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation

**Official Title:** Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

#### Organization Study ID Info
**ID:** CDR0000328247
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
#### Secondary ID Infos
**ID:** BCM-H-8447
### Status Module
#### Completion Date
**Date:** 2004-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2004-04

**Type:** ACTUAL

#### Start Date
**Date:** 2003-04

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2003-12-11
**Type:** ESTIMATED
**Study First Submit Date:** 2003-12-10
**Study First Submit QC Date:** 2003-12-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Baylor College of Medicine

#### Responsible Party

**Investigator Affiliation:** Baylor College of Medicine

**Investigator Full Name:** Helen Heslop

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).

**Detailed Description:** OBJECTIVES:

* Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation.

OUTLINE: This is a pilot, multicenter study.

* Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2.
* Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days.

Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation.

PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study.

### Conditions Module

**Conditions:**

- Kidney Cancer

**Keywords:**

- stage IV renal cell cancer

- recurrent renal cell cancer

### Design Module

#### Design Info

**Primary Purpose:** TREATMENT

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** alemtuzumab

**Type:** BIOLOGICAL

#### Intervention 2

**Name:** graft-versus-tumor induction therapy

**Type:** BIOLOGICAL

#### Intervention 3

**Name:** cyclophosphamide

**Type:** DRUG

#### Intervention 4

**Name:** fludarabine phosphate

**Type:** DRUG

#### Intervention 5

**Name:** allogeneic bone marrow transplantation

**Type:** PROCEDURE

#### Intervention 6

**Name:** peripheral blood stem cell transplantation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of patients with treatment related mortality

**Time Frame:** 100

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Diagnosis of recurrent or metastatic renal cell carcinoma
* Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
* Clinically evident and followable disease
* Availability of 1 of the following compatible donors:

  * Related HLA-identical or 1-Ag mismatched donor
  * Unrelated HLA-A, B, DRB1-matched donor

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Karnofsky 70-100%

Life expectancy

* No concurrent illness that severely limits life expectancy

Hematopoietic

* Not specified

Hepatic

* No episode of hepatitis within the past month
* No evidence of chronic active hepatitis or cirrhosis

Renal

* Creatinine no greater than 2 mg/dL

Cardiovascular

* LVEF at least 40%
* No uncontrolled arrhythmias
* No symptomatic cardiac disease

Pulmonary

* FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active infection
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** Baylor College of Medicine

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** Baylor College of Medicine

**Name:** Uday Popat, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Kidney Cancer

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: HIGH

- As Found: Kidney Cancer

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002292

- Term: Carcinoma, Renal Cell

- ID: D000007680

- Term: Kidney Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M283230

- Name: Fludarabine

- Relevance: HIGH

- As Found: Comparison

- ID: M225513

- Name: Fludarabine phosphate

- Relevance: HIGH

- As Found: Intubation

- ID: M1347

- Name: Alemtuzumab

- Relevance: HIGH

- As Found: SOC

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003520

- Term: Cyclophosphamide

- ID: C000024352

- Term: Fludarabine

- ID: C000042382

- Term: Fludarabine phosphate

- ID: D000074323

- Term: Alemtuzumab

### Misc Info Module

- Version Holder: 2024-05-24
