Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, Mantle-Cell

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphosarcoma

Mantle Cell Lymphoma

Hodgkin Lymphoma

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart.

Three intramuscular injections of matched placebo administered approximately 3 months apart.

LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.

Leuprolide acetate depot (LAD) 11.25 mg 3 Month

Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6.

Matched placebo

Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation.

This Phase 2 study will be conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation. Patients will be randomized to receive either LAD 11.25 mg 3 Month treatment or placebo and all patients will be vaccinated with KLH 6 months posttransplant. Patients will be evaluated to determine if the rate of immunologic recovery in the LAD group is enhanced compared with the placebo group.

A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation

Leuprolide Acetate to Enhance Immune Function Post-Autologous Stem Cell Transplantation

Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.

Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.

Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.

CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010

The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells.

CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010

The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells.

Norwood Immunology Limited

M.D. Anderson Cancer Center

Dana-Farber Cancer Institute

Abbott

Kristof Chwalisz, Therapeutic Area Head

Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.

Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month

Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.

Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

The study was terminated early because of slow enrollment. For the primary endpoint, changes from baseline within each treatment group were analyzed. Between treatment group comparisons were not performed because the sample size was too small.

Global Medical Services

Mean IgM at baseline (mcg/mL)

Mean IgM change from baseline (mcg/mL)

Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo

The final on treatment values were included in the analysis.

Baseline TREC per 100,000 CD4+ cells

Mean change in TREC from baseline to final visit

Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant

Baseline mean for TREC per 100,000 CD8+ cells

Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant

Mean IgG1 at baseline (mcg/mL)

Mean IgG1 change from baseline (mcg/mL)

Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo

Mean interferon gamma at baseline

Mean interferon gamma change from baseline

Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Saracatinib

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Iain McNeish

The purpose of this study is to investigate whether the addition of the Src inhibitor saracatinib (AZD0530) to weekly paclitaxel improves efficacy, compared with paclitaxel plus placebo, in patients with relapsed platinum-resistant ovarian cancer. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.

A multicentre, randomised, double-blind, placebo-controlled Phase II trial will be conducted. The overall aim of the trial is to investigate whether the addition of saracatinib to weekly paclitaxel improves efficacy, as measured by progression free survival, compared with paclitaxel plus placebo. The trial will also determine toxicity and ascertain whether the combination of paclitaxel plus saracatinib should proceed to a phase III trial.

The toxicity data from Study NCT00610714 (D8180C00015) suggests that a small number of patients could experience febrile neutropaenia during their first chemotherapy cycle. To combat this, saracatinib (175 mg OD)/matched placebo will begin 1 week prior to commencement of chemotherapy, and be given continuously until progression.

All patients will receive cycles of weekly paclitaxel chemotherapy. One cycle will consist of weekly paclitaxel (80 mg/m2) for 6 weeks followed by 2 weeks rest. If there is evidence of on-going response after 4 cycles, 3 further cycles of saracatinib/placebo plus weekly paclitaxel will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer

A Randomised Placebo-controlled Trial of Saracatinib (AZD0530) Plus Weekly Paclitaxel in Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis.

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

Duration of Response will be calculated by the trial statistician during the final analysis.

The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.

PWB 7 questions, lower values=better QoL.

FWB 7 questions, higher values=better QoL.

Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)

The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL.

Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.

Time To Progression will be calculated by the trial statistician during the final analysis.

AstraZeneca

Cancer Research UK

University College, London

According to Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Saracatinib Plus Weekly Paclitaxel

Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.

Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression

Placebo Plus Weekly Paclitaxel

Age, Continuous

United Kingdom

Cancer Antigen 125 (CA125)

ECOG PS 0 = Fully active, able to carry out all normal (pre-disease) activity without restriction

ECOG PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out light work, e.g. light house work, office work

ECOG PS 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Unknown

STAGE I: Tumour confined to ovaries

STAGE II: Tumour involves one or both ovaries with pelvic extension (below the pelvic brim) or primary peritoneal cancer

STAGE III: Tumour involves one or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastasis to the retroperitoneal lymph nodes

STAGE IV: Distant metastasis excluding peritoneal metastasis

International Federation of Gynecology and Obstetrics(FIGO) Ovarian Cancer Staging at diagnosis

High grade serous

Low grade serous

Clear cell

Grade 3 endometrioid

Grade 1/2 endometrioid

Undifferentiated

Histological subtype

Prior Surgery

<6 months

>=6 months/None

Prior Taxane Interval

Number of lines of Prior Chemotherapy

Prof Iain McNeish, Professor of Gynaecological Oncology

6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)

Overall Survival

Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria

Median Duration of Response

Quality of Life: Trial Outcome Index (TOI) Based on FACT-O

Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria

Median PFS

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Xerostomia

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Central Nervous System Depressants

Other Dietary Supplements

Melatonin

Antioxidants

Protective Agents

Drug: match placebo Drug: placebo suspension gargle for 2 minutes before radiation 15 minutes and placebo gelatin capsule taken orally after 21:00 hours each night throughout the study

Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study

Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study

Matched Placebo

The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H\&N), pain (VAS 0-10) and adverse event frequency.

Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients

Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients

Participants will be followed for severity of mucositis during the treatment period of 7 weeks

Participants will be followed for severity of xerostomia during the treatment period of 7 weeks

Ubon Ratchathani Cancer Hospital, Ubon Ratchathani

General Drugs House Co.,LTD.

Khon Kaen University

Behaviors and Mental Disorders

Quality of Life

Matched placebo (identical formulation and delivery, without active ingredient)

10 mg Melatonin

20 mg Melatonin

Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.

Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial

Melatonin In Cancer Patients Receiving Chemotherapy: A Randomized, Double Blind, Placebo, Controlled Trial

Self-reported questionnaires. FACT-L, FACT-B, FACT-H\&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H\&N and FACT-G are used in lung, breast, head\&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment.

8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation	NCT00275262	Hodgkin Disease Lymphoma, Non-H... Multiple Myelom... Mantle Cell Lym...	Leuprolide acet... Matched placebo	18 Years - 65 Years	Abbott
Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer	NCT01196741	Ovarian Cancer Fallopian Tube ... Primary Periton...	Paclitaxel Saracatinib Matched placebo	18 Years -	University College, London
Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients	NCT02430298	Head and Neck C...	Melatonin Matched Placebo	18 Years - 60 Years	Khon Kaen University
Melatonin In Reduction of Chemotherapy-Induced Toxicity (MIRCIT) Trial	NCT01706627	Advanced Stage ...	10 mg Melatonin 20 mg Melatonin Matched placebo	18 Years - 70 Years	Khon Kaen University
Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy	NCT00593853	Prostatic Neopl... Fatigue	Methylphenidate... Matched Placebo	18 Years - 85 Years	University Health Network, Toronto
A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation	NCT00275262	Hodgkin Disease Lymphoma, Non-H... Multiple Myelom... Mantle Cell Lym...	Leuprolide acet... Matched placebo	18 Years - 65 Years	Abbott

Spots Global Cancer Trial Database for matched placebo